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Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

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ClinicalTrials.gov Identifier: NCT00139776
Recruitment Status : Completed
First Posted : August 31, 2005
Results First Posted : May 19, 2009
Last Update Posted : July 9, 2009
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoarthritis, Knee
Osteoarthritis, Hip
Intervention Drug: Celecoxib
Enrollment 875
Recruitment Details 111 centers in the Americas and Europe enrolled and treated subjects (2 centers in Belgium, 4 centers in Brazil, 20 centers in Canada, 5 centers in Chile, 5 centers in Columbia, 1 center in France, 15 centers in the United Kingdom, and 59 centers in the United States).
Pre-assignment Details 17 participants completed Open-label run-in Period II and were randomized to Period III Double Blind but not treated.
Arm/Group Title Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories Open-Label Celecoxib Run-in Period Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare. Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study). Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed. Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Period Title: Period I
Started 1772 0 0 0
Completed 1197 0 0 0
Not Completed 575 0 0 0
Reason Not Completed
Did not enter Period II             575             0             0             0
Period Title: Period II
Started 0 1197 0 0
Completed 0 875 0 0
Not Completed 0 322 0 0
Reason Not Completed
Not Randomized into Period III             0             322             0             0
Period Title: Period III
Started 0 0 431 [1] 427 [2]
Completed 0 0 355 321
Not Completed 0 0 76 106
Reason Not Completed
Adverse Event             0             0             22             23
Other             0             0             23             34
Lack of Efficacy             0             0             10             24
Lost to Follow-up             0             0             5             4
Withdrawal by Subject             0             0             16             21
[1]
Randomized 440: 9 participants not treated
[2]
Randomized 435: 8 participants not treated
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use Total
Hide Arm/Group Description Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed. Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed. Total of all reporting groups
Overall Number of Baseline Participants 431 427 858
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 431 participants 427 participants 858 participants
58.5  (10.00) 58.7  (9.6) 58.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 427 participants 858 participants
Female
317
  73.5%
303
  71.0%
620.0
Male
114
  26.5%
124
  29.0%
238.0
1.Primary Outcome
Title Number of Flare Events Per Time of Exposure to Study Medication
Hide Description Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: flare events per month
0.54  (0.74) 0.93  (1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments

Null hypothesis for primary outcome is that there is no difference in the number of flares observed between the 2 treatment arms of celecoxib 200mg continuous use and celecoxib 200mg intermittent use.

Sample size calculation: Sufficient number of participants were randomized to provide at least 80% power to detect an estimated effect size of 0.2 using a 2-sided t-test at a 0.05 significant level.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method ANOVA
Comments Treatment as fixed effect
2.Secondary Outcome
Title Time to Occurrence of First Osteoarthritis (OA) Flare
Hide Description Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Median (95% Confidence Interval)
Unit of Measure: days
16.0
(14.0 to 22.0)
8.0
(8.0 to 9.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Kaplan-Meier analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Days Free From Osteoarthritis (OA) Flare
Hide Description Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: proportion of days free from OA flare
0.77  (0.28) 0.67  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method ANOVA
Comments Treatment as fixed effect
4.Secondary Outcome
Title Proportion of Days in Osteoarthritis (OA) Flare
Hide Description Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: proportion of days in OA flare
0.23  (0.28) 0.33  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method ANOVA
Comments Treatment as fixed effect
5.Secondary Outcome
Title Arthritis Pain Numerical Rating Scale (NRS)
Hide Description Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Time Frame Period III
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II.

Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale * weeks
Week 4 (n=415 cont; n=414 inter) 81.7  (1.1) 90.5  (1.1)
Week 8 (n=401 cont; n=395 inter) 148.8  (2.6) 167.0  (2.6)
Week 12 (n=383 cont; n=363 inter) 212.6  (4.1) 234.3  (4.1)
Week 16 (n=373 cont; n=339 inter) 272.7  (5.9) 297.6  (5.9)
Week 20 (n=362; n=323 inter) 335.9  (7.8) 361.1  (7.8)
Week 24 (n=350 cont; n=403 inter) 378.1  (9.1) 403.9  (9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 20
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
6.Secondary Outcome
Title Patient's Global Assessment of Arthritis
Hide Description Participant's response to question "Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today?" on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Time Frame Period III
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II.

Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale * weeks
Week 4 (n=415 cont; n=414 inter) 67.9  (0.68) 71.7  (0.69)
Week 8 (n=401 cont; n=395 inter) 126.0  (1.55) 133.2  (1.56)
Week 12 (n=383 cont; n=363 inter) 182.8  (2.48) 188.7  (2.48)
Week 16 (n=373 cont; n=339 inter) 236.3  (3.59) 241.2  (3.59)
Week 20 (n=362 cont; n=323 inter) 292.4  (4.83) 293.8  (4.84)
Week 24 (n=350 cont; n=309 inter) 329.2  (5.75) 328.9  (5.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.338
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 20
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.832
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.972
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
7.Secondary Outcome
Title Physician's Global Assessment of Arthritis at Final Visit
Hide Description Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Measure Type: Number
Unit of Measure: participants
Grade 1 (very good) 68 39
Grade 2 (good) 242 244
Grade 3 (fair) 91 113
Grade 4 (poor) 23 27
Grade 5 (very poor) 2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments Overall p-value Threshold for statistical significance p<0.05
Method Cochran-Mantel-Haenszel
Comments Test of row mean score differences based on modified ridits (standardizing the mid-rank)
8.Secondary Outcome
Title Total Rescue Medication Taken (Mean)
Hide Description Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Subjects who did not take rescue medication were assumed to have taken 0mg and were included in the analysis.

Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.

Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: mg taken per month per participant
1566  (4840) 2428  (4974)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments Threshold for statistical significance p<0.05
Method ANOVA
Comments Treatment as fixed effect
9.Secondary Outcome
Title Proportion of Days on Rescue Medication
Hide Description Days on rescue medication divided by number of days on study medication in Period III
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.

Subjects who did not take rescue medication were calculated as 0 and included in the analysis.

Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: proportion of days
0.044  (0.102) 0.069  (0.121)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments Threshold for statistical significance p<0.05
Method ANOVA
Comments Treatment as fixed effect
10.Secondary Outcome
Title Days on Flare Medication
Hide Description Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Subjects who did not take flare medication were calculated as 0 and included in the analysis.

Number of subjects taking flare medication: continuous use n=282; intermittent use n=339.

Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: days on medication per month per subject
6.589  (8.589) 9.793  (9.253)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method ANOVA
Comments Treatment as fixed effect
11.Secondary Outcome
Title Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Hide Description Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Total WOMAC score 1.60  (0.71) 4.99  (0.71)
WOMAC pain subscale 0.37  (0.15) 1.18  (0.15)
WOMAC stiffness subscale 0.12  (0.07) 0.40  (0.07)
WOMAC physical function subscale 1.13  (0.51) 3.43  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Total WOMAC score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use
Comments Total WOMAC score - Continuous use
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.60
Confidence Interval 95%
0.21 to 2.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.71
Estimation Comments Change in LSmean (score at end of Period III minus score at start of Period III)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Intermittent Use
Comments Total WOMAC score - Intermittent use
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.99
Confidence Interval 95%
3.60 to 6.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.71
Estimation Comments Change in LSmean (score at end of Period III minus score at start of Period III)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments WOMAC pain subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use
Comments WOMAC pain subscale - Continuous use
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval 95%
0.06 to 0.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments Change in LSmean (score at end of Period III minus score at start of Period III)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Intermittent Use
Comments WOMAC pain subscale - Intermittent use
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.18
Confidence Interval 95%
0.88 to 1.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments Change in LSmean (score at end of Period III minus score at start of Period III)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments WOMAC stiffness subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use
Comments WOMAC stiffness subscale - Continuous use
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval 95%
-0.02 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments Change in LSmean (score at end of Period III minus score at start of Period III)
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Intermittent Use
Comments WOMAC stiffness subscale - Intermittent use
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval 95%
0.26 to 0.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments Change in LSmean (score at end of Period III minus score at start of Period III)
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments WOMAC physical function subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use
Comments WOMAC physical function subscale - Continuous use
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.13
Confidence Interval 95%
0.13 to 2.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.51
Estimation Comments Change in LSmean (score at end of Period III minus score at start of Period III)
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Intermittent Use
Comments WOMAC physical function subscale - Intermittent use
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.43
Confidence Interval 95%
2.42 to 4.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.51
Estimation Comments Change in LSmean (score at end of Period III minus score at start of Period III)
12.Secondary Outcome
Title Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Hide Description WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.
Time Frame Period III (22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424

Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: scores on a scale * weeks
Total WOMAC score 604.9  (313.10) 693.6  (317.30)
WOMAC pain subscale 119.2  (63.36) 138.4  (65.95)
WOMAC stiffness subscale 54.5  (27.57) 62.1  (27.7)
WOMAC physical function subscale 431.4  (229.38) 493.6  (230.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments WOMAC total score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments WOMAC pain subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments WOMAC stiffness subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments WOMAC physical function subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
13.Other Pre-specified Outcome
Title Change in Medical Outcomes Study Sleep Scale - All Assessments
Hide Description Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.
Time Frame Period III
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Sleep disturbance (n=415 cont; n=410 inter) 0.5  (15.95) -1.4  (15.55)
Snoring (n=415 cont; n=412 inter) 0.9  (22.36) 0.7  (21.73)
Awaken short of breath (n=417 cont; n=411 inter) 1.9  (16.14) 1.1  (20.00)
Quantity of sleep (n=417 cont; n=413 inter) -0.1  (0.91) -0.1  (0.89)
Sleep adequacy (n=416 cont; n=413 inter) 0.1  (24.47) -1.3  (22.26)
Somnolence (n=416 cont; n=413 inter) 1.4  (14.55) 0.6  (13.70)
Sleep problems index I (n=416 cont; n=410 inter) 0.9  (13.20) 0.5  (13.18)
Sleep problems index II (n=413 cont; n=408 inter) 0.7  (12.29) -0.1  (12.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Sleep disturbance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2712
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Snoring
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8737
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Awaken short of breath
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7703
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Quantity of sleep
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3769
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Sleep adequacy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4075
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Somnolence
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5854
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Sleep problems index I
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8358
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Sleep problems index II
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5878
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
14.Other Pre-specified Outcome
Title Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep
Hide Description Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III
Time Frame Period III
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Measure Type: Number
Unit of Measure: participants
Optimal (all scores are 1) 139 123
Mixed (scores are both 1 and 0) 166 165
Not optimal (all scores are 0) 115 132
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Analysis across all 3 sleep scores for Period III
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1437
Comments Threshold for statistical significance p<0.05
Method Cochran-Mantel-Haenszel
Comments by general association
15.Other Pre-specified Outcome
Title Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Hide Description SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.
Time Frame Period III
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)

Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description:
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Overall Number of Participants Analyzed 431 427
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical function (n=417 cont; n=413 inter) 1.8  (23.03) -3.2  (22.77)
Role physical (n=416 cont; n=412 inter) 3.5  (19.93) -1.1  (20.07)
Bodily pain (n=417 cont; n=414 inter) 3.8  (20.11) -0.3  (21.56)
General health (n=417 cont; n=414 inter) -0.3  (17.60) -0.8  (17.27)
Vitality (n=416 cont; n=414 inter) 0.3  (20.43) -3.5  (18.34)
Social functioning (n=416 cont; n=414 inter) -1.9  (20.16) -3.5  (22.37)
Role emotional (n=417 cont; n=413 inter) -0.7  (18.62) -2.1  (19.80)
Mental health (n=416 cont; n=413 inter) -0.9  (15.57) -1.3  (16.05)
Physical component summary(n=416 cont;n=411 inter) 9.0  (55.55) -5.2  (57.48)
Mental component summary (n=416 cont;n=411 inter) -3.1  (51.59) -10.5  (55.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Physical function
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Role physical
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Bodily pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments General health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3097
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Vitality
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0139
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Social functioning
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1303
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Role emotional
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1404
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Mental health
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4015
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Physical component summary
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Celecoxib 200mg Continuous Use, Celecoxib 200mg Intermittent Use
Comments Mental component summary
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0301
Comments Threshold for statistical significance p<0.05
Method ANCOVA
Comments Treatment as fixed effect and baseline as covariate
16.Other Pre-specified Outcome
Title Serious Adverse Events in Open Label run-in Period
Hide Description Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily
Time Frame 2 weeks prior to double blind dosing
Hide Outcome Measure Data
Hide Analysis Population Description
1197 participants entered the open-label run-in (period II) to allow observation of successful treatment of an osteoarthritis flare. 875 participants were randomized to double blind treatment (period III). 322 participants were not randomized.
Arm/Group Title Celecoxib 200mg Open Label
Hide Arm/Group Description:
Period II run-in (2 weeks). Celecoxib 200 mg daily until resolution of screening osteoarthritis flare as defined by IVRS
Overall Number of Participants Analyzed 1197
Measure Type: Number
Unit of Measure: participants
Anaemia 1
Vitreous haemorrhage 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Hide Arm/Group Description Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed. Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
All-Cause Mortality
Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Affected / at Risk (%) Affected / at Risk (%)
Total   6   10 
Cardiac disorders     
Atrial fibrillation  1  1/431 (0.23%)  0/427 (0.00%) 
Coronary artery disease  1  1/431 (0.23%)  0/427 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/431 (0.00%)  1/427 (0.23%) 
Gastritis  1  0/431 (0.00%)  1/427 (0.23%) 
Melaena  1  1/431 (0.23%)  0/427 (0.00%) 
Pancreatitis  1  0/431 (0.00%)  1/427 (0.23%) 
Rectal haemorrhage  1  1/431 (0.23%)  0/427 (0.00%) 
General disorders     
Chest pain  1  1/431 (0.23%)  1/427 (0.23%) 
Non-cardiac chest pain  1  0/431 (0.00%)  1/427 (0.23%) 
Injury, poisoning and procedural complications     
Skin laceration  1  0/431 (0.00%)  1/427 (0.23%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/431 (0.00%)  2/427 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system  1  1/431 (0.23%)  0/427 (0.00%) 
Squamous cell carcinoma  1  0/431 (0.00%)  1/427 (0.23%) 
Nervous system disorders     
Transient ischaemic attack  1  0/431 (0.00%)  1/427 (0.23%) 
Psychiatric disorders     
Bipolar I disorder  1  0/431 (0.00%)  1/427 (0.23%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/431 (0.23%)  0/427 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/431 (0.23%)  0/427 (0.00%) 
Pulmonary oedema  1  1/431 (0.23%)  0/427 (0.00%) 
Surgical and medical procedures     
Knee arthroplasty  1  0/431 (0.00%)  1/427 (0.23%) 
Vascular disorders     
Hypertensive crisis  1  0/431 (0.00%)  1/427 (0.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celecoxib 200mg Continuous Use Celecoxib 200mg Intermittent Use
Affected / at Risk (%) Affected / at Risk (%)
Total   242   246 
Blood and lymphatic system disorders     
Anaemia  1  1/431 (0.23%)  0/427 (0.00%) 
Lymphadenopathy  1  1/431 (0.23%)  2/427 (0.47%) 
Cardiac disorders     
Angina pectoris  1  1/431 (0.23%)  0/427 (0.00%) 
Bundle branch block left  1  1/431 (0.23%)  0/427 (0.00%) 
Extrasystoles  1  1/431 (0.23%)  0/427 (0.00%) 
Hypertensive heart disease  1  0/431 (0.00%)  1/427 (0.23%) 
Sinus tachycardia  1  0/431 (0.00%)  1/427 (0.23%) 
Tachycardia  1  1/431 (0.23%)  0/427 (0.00%) 
Ear and labyrinth disorders     
Cerumen impaction  1  1/431 (0.23%)  1/427 (0.23%) 
Deafness  1  1/431 (0.23%)  0/427 (0.00%) 
Ear disorder  1  1/431 (0.23%)  0/427 (0.00%) 
Ear pain  1  2/431 (0.46%)  2/427 (0.47%) 
Eustachian tube dysfunction  1  0/431 (0.00%)  1/427 (0.23%) 
Tympanic membrane disorder  1  1/431 (0.23%)  0/427 (0.00%) 
Vertigo  1  5/431 (1.16%)  3/427 (0.70%) 
Endocrine disorders     
Goitre  1  1/431 (0.23%)  0/427 (0.00%) 
Hypothyroidism  1  0/431 (0.00%)  1/427 (0.23%) 
Eye disorders     
Cataract  1  0/431 (0.00%)  1/427 (0.23%) 
Conjunctivitis  1  1/431 (0.23%)  0/427 (0.00%) 
Conjunctivitis allergic  1  1/431 (0.23%)  0/427 (0.00%) 
Diplopia  1  1/431 (0.23%)  0/427 (0.00%) 
Dry eye  1  2/431 (0.46%)  0/427 (0.00%) 
Eye allergy  1  1/431 (0.23%)  0/427 (0.00%) 
Eye irritation  1  0/431 (0.00%)  1/427 (0.23%) 
Glaucoma  1  1/431 (0.23%)  0/427 (0.00%) 
Lacrimation increased  1  1/431 (0.23%)  1/427 (0.23%) 
Myodesopsia  1  0/431 (0.00%)  1/427 (0.23%) 
Vision blurred  1  2/431 (0.46%)  1/427 (0.23%) 
Visual acuity reduced  1  1/431 (0.23%)  0/427 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/431 (0.23%)  1/427 (0.23%) 
Abdominal distension  1  3/431 (0.70%)  1/427 (0.23%) 
Abdominal hernia  1  1/431 (0.23%)  0/427 (0.00%) 
Abdominal pain  1  10/431 (2.32%)  3/427 (0.70%) 
Abdominal pain lower  1  1/431 (0.23%)  0/427 (0.00%) 
Abdominal pain upper  1  7/431 (1.62%)  10/427 (2.34%) 
Aphthous stomatitis  1  1/431 (0.23%)  0/427 (0.00%) 
Breath odour  1  0/431 (0.00%)  1/427 (0.23%) 
Colitis  1  1/431 (0.23%)  2/427 (0.47%) 
Constipation  1  5/431 (1.16%)  4/427 (0.94%) 
Dental caries  1  0/431 (0.00%)  1/427 (0.23%) 
Diarrhoea  1  7/431 (1.62%)  17/427 (3.98%) 
Dry mouth  1  1/431 (0.23%)  0/427 (0.00%) 
Dyspepsia  1  17/431 (3.94%)  6/427 (1.41%) 
Eructation  1  0/431 (0.00%)  1/427 (0.23%) 
Flatulence  1  2/431 (0.46%)  0/427 (0.00%) 
Frequent bowel movements  1  1/431 (0.23%)  0/427 (0.00%) 
Gastritis  1  5/431 (1.16%)  2/427 (0.47%) 
Gastrooesophageal reflux disease  1  4/431 (0.93%)  3/427 (0.70%) 
Gastrooesophagitis  1  1/431 (0.23%)  0/427 (0.00%) 
Gingival pain  1  1/431 (0.23%)  1/427 (0.23%) 
Haematochezia  1  0/431 (0.00%)  1/427 (0.23%) 
Haemorrhoids  1  1/431 (0.23%)  1/427 (0.23%) 
Inguinal hernia  1  0/431 (0.00%)  1/427 (0.23%) 
Irritable bowel syndrome  1  3/431 (0.70%)  3/427 (0.70%) 
Mouth ulceration  1  1/431 (0.23%)  0/427 (0.00%) 
Nausea  1  5/431 (1.16%)  9/427 (2.11%) 
Oral pain  1  0/431 (0.00%)  1/427 (0.23%) 
Paraesthesia oral  1  1/431 (0.23%)  0/427 (0.00%) 
Parotid gland enlargement  1  0/431 (0.00%)  1/427 (0.23%) 
Peptic ulcer  1  1/431 (0.23%)  0/427 (0.00%) 
Proctitis  1  0/431 (0.00%)  1/427 (0.23%) 
Rectal haemorrhage  1  1/431 (0.23%)  1/427 (0.23%) 
Stomach discomfort  1  4/431 (0.93%)  1/427 (0.23%) 
Stomatitis  1  1/431 (0.23%)  0/427 (0.00%) 
Tongue disorder  1  0/431 (0.00%)  1/427 (0.23%) 
Toothache  1  3/431 (0.70%)  6/427 (1.41%) 
Vomiting  1  5/431 (1.16%)  6/427 (1.41%) 
General disorders     
Asthenia  1  1/431 (0.23%)  0/427 (0.00%) 
Chest discomfort  1  1/431 (0.23%)  0/427 (0.00%) 
Chest pain  1  2/431 (0.46%)  4/427 (0.94%) 
Fatigue  1  6/431 (1.39%)  9/427 (2.11%) 
Feeling hot  1  0/431 (0.00%)  1/427 (0.23%) 
Gravitational oedema  1  0/431 (0.00%)  1/427 (0.23%) 
Hypothermia  1  0/431 (0.00%)  1/427 (0.23%) 
Influenza like illness  1  1/431 (0.23%)  4/427 (0.94%) 
Malaise  1  0/431 (0.00%)  1/427 (0.23%) 
Oedema peripheral  1  4/431 (0.93%)  12/427 (2.81%) 
Pain  1  6/431 (1.39%)  9/427 (2.11%) 
Pyrexia  1  2/431 (0.46%)  5/427 (1.17%) 
Swelling  1  0/431 (0.00%)  1/427 (0.23%) 
Thirst  1  0/431 (0.00%)  1/427 (0.23%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/431 (0.23%)  0/427 (0.00%) 
Immune system disorders     
Hypersensitivity  1  0/431 (0.00%)  1/427 (0.23%) 
Seasonal allergy  1  2/431 (0.46%)  1/427 (0.23%) 
Infections and infestations     
Alveolar osteitis  1  0/431 (0.00%)  1/427 (0.23%) 
American trypanosomiasis  1  0/431 (0.00%)  1/427 (0.23%) 
Amoebiasis  1  0/431 (0.00%)  1/427 (0.23%) 
Bronchitis  1  4/431 (0.93%)  9/427 (2.11%) 
Cellulitis  1  2/431 (0.46%)  2/427 (0.47%) 
Cystitis  1  1/431 (0.23%)  4/427 (0.94%) 
Diverticulitis  1  0/431 (0.00%)  1/427 (0.23%) 
Ear infection  1  1/431 (0.23%)  0/427 (0.00%) 
Fungal skin infection  1  0/431 (0.00%)  1/427 (0.23%) 
Gastroenteritis  1  2/431 (0.46%)  0/427 (0.00%) 
Gastroenteritis viral  1  1/431 (0.23%)  1/427 (0.23%) 
Groin abscess  1  0/431 (0.00%)  1/427 (0.23%) 
Herpes zoster  1  1/431 (0.23%)  3/427 (0.70%) 
Infected bites  1  1/431 (0.23%)  0/427 (0.00%) 
Influenza  1  10/431 (2.32%)  9/427 (2.11%) 
Labyrinthitis  1  1/431 (0.23%)  1/427 (0.23%) 
Laryngitis  1  1/431 (0.23%)  0/427 (0.00%) 
Localised infection  1  2/431 (0.46%)  0/427 (0.00%) 
Lower respiratory tract infection  1  1/431 (0.23%)  1/427 (0.23%) 
Lymph gland infection  1  1/431 (0.23%)  0/427 (0.00%) 
Nail infection  1  1/431 (0.23%)  0/427 (0.00%) 
Nasopharyngitis  1  19/431 (4.41%)  20/427 (4.68%) 
Onychomycosis  1  1/431 (0.23%)  1/427 (0.23%) 
Oral herpes  1  1/431 (0.23%)  0/427 (0.00%) 
Osteomyelitis  1  0/431 (0.00%)  1/427 (0.23%) 
Otitis externa  1  1/431 (0.23%)  0/427 (0.00%) 
Otitis media  1  0/431 (0.00%)  1/427 (0.23%) 
Otitis media acute  1  0/431 (0.00%)  1/427 (0.23%) 
Parasitic gastroenteritis  1  0/431 (0.00%)  1/427 (0.23%) 
Pharyngitis  1  4/431 (0.93%)  3/427 (0.70%) 
Pharyngitis streptococcal  1  1/431 (0.23%)  0/427 (0.00%) 
Pyelonephritis  1  1/431 (0.23%)  0/427 (0.00%) 
Pyoderma  1  1/431 (0.23%)  1/427 (0.23%) 
Rhinitis  1  1/431 (0.23%)  1/427 (0.23%) 
Sinusitis  1  11/431 (2.55%)  10/427 (2.34%) 
Sinusitis bacterial  1  1/431 (0.23%)  0/427 (0.00%) 
Tonsillitis  1  1/431 (0.23%)  0/427 (0.00%) 
Tooth abscess  1  1/431 (0.23%)  0/427 (0.00%) 
Tooth infection  1  0/431 (0.00%)  1/427 (0.23%) 
Upper respiratory tract infection  1  14/431 (3.25%)  19/427 (4.45%) 
Urinary tract infection  1  7/431 (1.62%)  7/427 (1.64%) 
Viral infection  1  3/431 (0.70%)  4/427 (0.94%) 
Viral pharyngitis  1  1/431 (0.23%)  0/427 (0.00%) 
Viral upper respiratory tract infection  1  1/431 (0.23%)  1/427 (0.23%) 
Vulvovaginal candidiasis  1  0/431 (0.00%)  1/427 (0.23%) 
Vulvovaginal mycotic infection  1  0/431 (0.00%)  2/427 (0.47%) 
Vulvovaginitis  1  0/431 (0.00%)  1/427 (0.23%) 
Wound infection  1  0/431 (0.00%)  1/427 (0.23%) 
Injury, poisoning and procedural complications     
Animal bite  1  0/431 (0.00%)  1/427 (0.23%) 
Arthropod bite  1  1/431 (0.23%)  0/427 (0.00%) 
Arthropod sting  1  1/431 (0.23%)  0/427 (0.00%) 
Back injury  1  0/431 (0.00%)  2/427 (0.47%) 
Burns second degree  1  0/431 (0.00%)  1/427 (0.23%) 
Contusion  1  3/431 (0.70%)  7/427 (1.64%) 
Device breakage  1  0/431 (0.00%)  1/427 (0.23%) 
Epicondylitis  1  4/431 (0.93%)  0/427 (0.00%) 
Excoriation  1  0/431 (0.00%)  2/427 (0.47%) 
Eye injury  1  1/431 (0.23%)  0/427 (0.00%) 
Fall  1  1/431 (0.23%)  2/427 (0.47%) 
Joint injury  1  3/431 (0.70%)  0/427 (0.00%) 
Joint sprain  1  2/431 (0.46%)  2/427 (0.47%) 
Limb crushing injury  1  0/431 (0.00%)  1/427 (0.23%) 
Limb injury  1  1/431 (0.23%)  0/427 (0.00%) 
Meniscus lesion  1  0/431 (0.00%)  1/427 (0.23%) 
Muscle injury  1  1/431 (0.23%)  0/427 (0.00%) 
Muscle strain  1  1/431 (0.23%)  2/427 (0.47%) 
Neck injury  1  0/431 (0.00%)  2/427 (0.47%) 
Post-traumatic pain  1  1/431 (0.23%)  0/427 (0.00%) 
Procedural pain  1  2/431 (0.46%)  0/427 (0.00%) 
Repetitive strain injury  1  1/431 (0.23%)  0/427 (0.00%) 
Rib fracture  1  0/431 (0.00%)  1/427 (0.23%) 
Skeletal injury  1  1/431 (0.23%)  1/427 (0.23%) 
Skin laceration  1  2/431 (0.46%)  0/427 (0.00%) 
Snake bite  1  1/431 (0.23%)  0/427 (0.00%) 
Thermal burn  1  0/431 (0.00%)  1/427 (0.23%) 
Tooth fracture  1  1/431 (0.23%)  0/427 (0.00%) 
Wrist fracture  1  1/431 (0.23%)  0/427 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/431 (0.23%)  0/427 (0.00%) 
Aspartate aminotransferase increased  1  1/431 (0.23%)  0/427 (0.00%) 
Blood cholesterol increased  1  0/431 (0.00%)  1/427 (0.23%) 
Blood creatinine increased  1  0/431 (0.00%)  2/427 (0.47%) 
Blood potassium increased  1  0/431 (0.00%)  1/427 (0.23%) 
Blood pressure increased  1  0/431 (0.00%)  4/427 (0.94%) 
Blood urea increased  1  0/431 (0.00%)  2/427 (0.47%) 
Blood urine present  1  0/431 (0.00%)  1/427 (0.23%) 
Cardiac murmur  1  0/431 (0.00%)  1/427 (0.23%) 
Gamma-glutamyltransferase increased  1  1/431 (0.23%)  0/427 (0.00%) 
Heart rate irregular  1  1/431 (0.23%)  0/427 (0.00%) 
Hepatic enzyme increased  1  1/431 (0.23%)  0/427 (0.00%) 
Hepatitis C positive  1  0/431 (0.00%)  1/427 (0.23%) 
Weight increased  1  1/431 (0.23%)  1/427 (0.23%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/431 (0.23%)  2/427 (0.47%) 
Fluid retention  1  1/431 (0.23%)  1/427 (0.23%) 
Hypercholesterolaemia  1  1/431 (0.23%)  1/427 (0.23%) 
Hyperglycaemia  1  1/431 (0.23%)  1/427 (0.23%) 
Hyperlipdaemia  1  0/431 (0.00%)  1/427 (0.23%) 
Hypertriglyceridaemia  1  1/431 (0.23%)  0/427 (0.00%) 
Increased appetite  1  1/431 (0.23%)  0/427 (0.00%) 
Polydipsia  1  0/431 (0.00%)  1/427 (0.23%) 
Vitamin D deficiency  1  0/431 (0.00%)  1/427 (0.23%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  17/431 (3.94%)  25/427 (5.85%) 
Arthritis  1  0/431 (0.00%)  2/427 (0.47%) 
Back pain  1  20/431 (4.64%)  31/427 (7.26%) 
Bone pain  1  3/431 (0.70%)  0/427 (0.00%) 
Bursitis  1  6/431 (1.39%)  2/427 (0.47%) 
Cervical spinal stenosis  1  1/431 (0.23%)  0/427 (0.00%) 
Coccydynia  1  1/431 (0.23%)  0/427 (0.00%) 
Costochondritis  1  1/431 (0.23%)  0/427 (0.00%) 
Fibromyalgia  1  1/431 (0.23%)  0/427 (0.00%) 
Flank pain  1  0/431 (0.00%)  1/427 (0.23%) 
Groin pain  1  1/431 (0.23%)  2/427 (0.47%) 
Intervertebral disc degeneration  1  0/431 (0.00%)  1/427 (0.23%) 
Joint stiffness  1  1/431 (0.23%)  2/427 (0.47%) 
Joint swelling  1  1/431 (0.23%)  1/427 (0.23%) 
Muscle spasms  1  10/431 (2.32%)  5/427 (1.17%) 
Muscular weakness  1  0/431 (0.00%)  1/427 (0.23%) 
Musculoskeletal chest pain  1  0/431 (0.00%)  2/427 (0.47%) 
Musculoskeletal pain  1  7/431 (1.62%)  12/427 (2.81%) 
Musculoskeletal stiffness  1  0/431 (0.00%)  2/427 (0.47%) 
Myalgia  1  10/431 (2.32%)  9/427 (2.11%) 
Neck pain  1  7/431 (1.62%)  7/427 (1.64%) 
Osteoarthritis  1  7/431 (1.62%)  2/427 (0.47%) 
Osteopenia  1  0/431 (0.00%)  1/427 (0.23%) 
Pain in extremity  1  18/431 (4.18%)  21/427 (4.92%) 
Pain in jaw  1  0/431 (0.00%)  2/427 (0.47%) 
Periarthritis  1  0/431 (0.00%)  1/427 (0.23%) 
Plantar fasciitis  1  0/431 (0.00%)  3/427 (0.70%) 
Rotator cuff syndrome  1  1/431 (0.23%)  0/427 (0.00%) 
Sacroiliitis  1  0/431 (0.00%)  1/427 (0.23%) 
Sensation of heaviness  1  0/431 (0.00%)  1/427 (0.23%) 
Spondyloarthropathy  1  0/431 (0.00%)  1/427 (0.23%) 
Synovial cyst  1  0/431 (0.00%)  2/427 (0.47%) 
Synovitis  1  1/431 (0.23%)  0/427 (0.00%) 
Temporomandibular joint syndrome  1  0/431 (0.00%)  1/427 (0.23%) 
Tendon pain  1  0/431 (0.00%)  2/427 (0.47%) 
Tendonitis  1  0/431 (0.00%)  2/427 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/431 (0.23%)  0/427 (0.00%) 
Melanocytic naevus  1  0/431 (0.00%)  1/427 (0.23%) 
Neoplasm  1  0/431 (0.00%)  1/427 (0.23%) 
Seborrhoeic keratosis  1  0/431 (0.00%)  1/427 (0.23%) 
Skin papilloma  1  0/431 (0.00%)  1/427 (0.23%) 
Thyroid neoplasm  1  1/431 (0.23%)  0/427 (0.00%) 
Nervous system disorders     
Carpal tunnel syndrome  1  1/431 (0.23%)  0/427 (0.00%) 
Cluster headache  1  1/431 (0.23%)  0/427 (0.00%) 
Dizziness  1  8/431 (1.86%)  8/427 (1.87%) 
Dysgeusia  1  1/431 (0.23%)  0/427 (0.00%) 
Facial palsy  1  0/431 (0.00%)  1/427 (0.23%) 
Headache  1  65/431 (15.08%)  68/427 (15.93%) 
Hypoaesthesia  1  1/431 (0.23%)  0/427 (0.00%) 
Lethargy  1  1/431 (0.23%)  0/427 (0.00%) 
Lumbar radiculopathy  1  0/431 (0.00%)  1/427 (0.23%) 
Migraine  1  1/431 (0.23%)  2/427 (0.47%) 
Migraine with aura  1  1/431 (0.23%)  0/427 (0.00%) 
Neuropathy peripheral  1  1/431 (0.23%)  0/427 (0.00%) 
Paraesthesia  1  2/431 (0.46%)  3/427 (0.70%) 
Poor quality sleep  1  1/431 (0.23%)  0/427 (0.00%) 
Restless legs syndrome  1  0/431 (0.00%)  1/427 (0.23%) 
Sciatica  1  1/431 (0.23%)  2/427 (0.47%) 
Sinus headache  1  2/431 (0.46%)  1/427 (0.23%) 
Somnolence  1  1/431 (0.23%)  1/427 (0.23%) 
Syncope  1  1/431 (0.23%)  0/427 (0.00%) 
Tension headache  1  0/431 (0.00%)  1/427 (0.23%) 
Tremor  1  2/431 (0.46%)  1/427 (0.23%) 
Psychiatric disorders     
Adjustment disorder  1  0/431 (0.00%)  1/427 (0.23%) 
Anxiety  1  4/431 (0.93%)  1/427 (0.23%) 
Attention deficit / hyperactivity disorder  1  1/431 (0.23%)  0/427 (0.00%) 
Confusional state  1  1/431 (0.23%)  0/427 (0.00%) 
Depressed mood  1  1/431 (0.23%)  0/427 (0.00%) 
Depression  1  5/431 (1.16%)  3/427 (0.70%) 
Disorientation  1  0/431 (0.00%)  1/427 (0.23%) 
Insomnia  1  11/431 (2.55%)  8/427 (1.87%) 
Libido decreased  1  2/431 (0.46%)  0/427 (0.00%) 
Nervousness  1  1/431 (0.23%)  0/427 (0.00%) 
Nightmare  1  1/431 (0.23%)  0/427 (0.00%) 
Restlessness  1  0/431 (0.00%)  1/427 (0.23%) 
Sleep disorder  1  0/431 (0.00%)  1/427 (0.23%) 
Stress  1  0/431 (0.00%)  1/427 (0.23%) 
Renal and urinary disorders     
Dysuria  1  2/431 (0.46%)  0/427 (0.00%) 
Haematuria  1  0/431 (0.00%)  1/427 (0.23%) 
Hypertonic bladder  1  1/431 (0.23%)  0/427 (0.00%) 
Micturition frequency decreased  1  0/431 (0.00%)  1/427 (0.23%) 
Nephrolithiasis  1  0/431 (0.00%)  2/427 (0.47%) 
Oliguria  1  0/431 (0.00%)  1/427 (0.23%) 
Pollakiuria  1  0/431 (0.00%)  2/427 (0.47%) 
Renal colic  1  0/431 (0.00%)  1/427 (0.23%) 
Renal pain  1  2/431 (0.46%)  0/427 (0.00%) 
Urine odour abnormal  1  1/431 (0.23%)  0/427 (0.00%) 
Reproductive system and breast disorders     
Adnexa uteri pain  1  1/431 (0.23%)  0/427 (0.00%) 
Breast mass  1  0/431 (0.00%)  1/427 (0.23%) 
Breast pain  1  1/431 (0.23%)  0/427 (0.00%) 
Dysmenorrhoea  1  2/431 (0.46%)  4/427 (0.94%) 
Erectile dysfunction  1  1/431 (0.23%)  1/427 (0.23%) 
Menorrhagia  1  0/431 (0.00%)  1/427 (0.23%) 
Menstrual disorder  1  0/431 (0.00%)  1/427 (0.23%) 
Uterine polyp  1  0/431 (0.00%)  2/427 (0.47%) 
Vulvovaginal dryness  1  0/431 (0.00%)  1/427 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  4/431 (0.93%)  2/427 (0.47%) 
Bronchial obstruction  1  0/431 (0.00%)  1/427 (0.23%) 
Chronic obstructive pulmonary disease  1  0/431 (0.00%)  1/427 (0.23%) 
Cough  1  4/431 (0.93%)  4/427 (0.94%) 
Dyspnoea  1  3/431 (0.70%)  3/427 (0.70%) 
Epistaxis  1  1/431 (0.23%)  0/427 (0.00%) 
Increased upper airway secretion  1  0/431 (0.00%)  1/427 (0.23%) 
Nasal congestion  1  5/431 (1.16%)  3/427 (0.70%) 
Nasal dryness  1  1/431 (0.23%)  0/427 (0.00%) 
Oropharyngeal pain  1  7/431 (1.62%)  4/427 (0.94%) 
Paranasal sinus hypersecretion  1  0/431 (0.00%)  1/427 (0.23%) 
Pharyngeal oedema  1  1/431 (0.23%)  0/427 (0.00%) 
Pleuritic pain  1  0/431 (0.00%)  1/427 (0.23%) 
Pulmonary congestion  1  1/431 (0.23%)  1/427 (0.23%) 
Rales  1  0/431 (0.00%)  1/427 (0.23%) 
Rhinitis allergic  1  3/431 (0.70%)  2/427 (0.47%) 
Rhinorrhoea  1  2/431 (0.46%)  0/427 (0.00%) 
Sinus congestion  1  3/431 (0.70%)  2/427 (0.47%) 
Wheezing  1  0/431 (0.00%)  1/427 (0.23%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  2/431 (0.46%)  0/427 (0.00%) 
Blister  1  1/431 (0.23%)  0/427 (0.00%) 
Dermatitis  1  0/431 (0.00%)  3/427 (0.70%) 
Dermatitis allergic  1  0/431 (0.00%)  1/427 (0.23%) 
Dermatitis contact  1  1/431 (0.23%)  0/427 (0.00%) 
Eczema  1  1/431 (0.23%)  0/427 (0.00%) 
Eczema asteatotic  1  1/431 (0.23%)  0/427 (0.00%) 
Erythema  1  2/431 (0.46%)  0/427 (0.00%) 
Hair texture abnormal  1  1/431 (0.23%)  0/427 (0.00%) 
Hyperkeratosis  1  0/431 (0.00%)  2/427 (0.47%) 
Increased tendency to bruise  1  1/431 (0.23%)  0/427 (0.00%) 
Ingrown hair  1  0/431 (0.00%)  1/427 (0.23%) 
Pruritus  1  3/431 (0.70%)  2/427 (0.47%) 
Rash  1  1/431 (0.23%)  7/427 (1.64%) 
Rash erythematous  1  0/431 (0.00%)  1/427 (0.23%) 
Rash papular  1  1/431 (0.23%)  0/427 (0.00%) 
Rash pruritic  1  1/431 (0.23%)  0/427 (0.00%) 
Scar  1  0/431 (0.00%)  1/427 (0.23%) 
Seborrhoea  1  0/431 (0.00%)  1/427 (0.23%) 
Skin discolouration  1  0/431 (0.00%)  1/427 (0.23%) 
Urticaria  1  1/431 (0.23%)  1/427 (0.23%) 
Surgical and medical procedures     
Myringoplasty  1  0/431 (0.00%)  1/427 (0.23%) 
Nail operation  1  0/431 (0.00%)  1/427 (0.23%) 
Tooth extraction  1  0/431 (0.00%)  1/427 (0.23%) 
Vasectomy  1  1/431 (0.23%)  0/427 (0.00%) 
Vascular disorders     
Flushing  1  0/431 (0.00%)  1/427 (0.23%) 
Hot flush  1  2/431 (0.46%)  0/427 (0.00%) 
Hypertension  1  9/431 (2.09%)  13/427 (3.04%) 
Systolic hypertension  1  1/431 (0.23%)  0/427 (0.00%) 
Varicose vein  1  0/431 (0.00%)  1/427 (0.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00139776     History of Changes
Other Study ID Numbers: A3191173
First Submitted: August 29, 2005
First Posted: August 31, 2005
Results First Submitted: February 20, 2009
Results First Posted: May 19, 2009
Last Update Posted: July 9, 2009