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Trial record 100 of 543 for:    Celecoxib

Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component

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ClinicalTrials.gov Identifier: NCT01838044
Recruitment Status : Terminated (Recruitment terminated on 3Apr2015 due to slow recruitment rate and lack of operational feasibility. Study was not terminated for reasons of safety/efficacy.)
First Posted : April 23, 2013
Results First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Low Back Pain With a Neuropathic Component
Interventions Drug: pregabalin and celecoxib
Drug: Placebo and celecoxib
Enrollment 180
Recruitment Details This study was conducted at 28 sites across 7 countries. From a total of 232 participants screened, 180 were randomized into Period 1 and 166 entered into Period 2.
Pre-assignment Details Participants who completed a minimum of 4 days per week of daily diaries during the 7 days preceding the baseline visit and had a mean weekly pain score >= 4 at the end of screening were randomized to either Arm A or Arm B.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment. During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Period Title: Overall Study
Started 89 91
Completed 81 75
Not Completed 8 16
Reason Not Completed
Adverse Event             4             6
Protocol Violation             3             3
Withdrawal by Subject             0             2
Insufficient clinical response             1             2
Medication error without associated AE             0             1
Lost to Follow-up             0             2
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment. During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment. Total of all reporting groups
Overall Number of Baseline Participants 89 91 180
Hide Baseline Analysis Population Description
Safety population was composed of all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 91 participants 180 participants
49.7  (11.7) 49.2  (12.2) 49.5  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 91 participants 180 participants
Female
65
  73.0%
63
  69.2%
128
  71.1%
Male
24
  27.0%
28
  30.8%
52
  28.9%
1.Primary Outcome
Title Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms
Hide Description The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame Baseline and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Mean (Standard Error)
Unit of Measure: Units on a scale
-2.18  (0.212) -2.03  (0.212)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Statistical analysis at Week 5 compared between two study arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.72 to 0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.287
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).
Hide Description The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame Week 5 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 91
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.42  (0.204)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B
Comments Statistical analysis of weekly mean pain NRS score in Arm B at Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
1.02 to 1.83
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms
Hide Description The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame Baseline and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.21  (0.262) -3.45  (0.265)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Statistical analysis of weekly mean pain NRS score in Arm B compared between two study arms at Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5128
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.48 to 0.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.361
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Benefit, Satisfaction, and Willingness to Continue Measure Scores Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
Hide Description The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6.
Time Frame Week 5 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Measure Type: Number
Unit of Measure: Percentage of participants
Benefit from Treatment - No benefit (Week 5) 10.1 6.6
Benefit from Treatment - Little benefit (Week 5) 22.5 29.7
Benefit from Treatment - Much benefit (Week 5) 61.8 53.8
Satisfaction from Treatment - DVN (Week 5) - Yes 78.7 84.6
Satisfaction from Treatment - DVN (Week 5) - No 15.7 5.5
A Little Satisfied (Week 5) 20.2 26.4
Very Satisfied (Week 5) 58.4 58.2
A Little Dissatisfied (Week 5) 12.4 4.4
Very Dissatisfied (Week 5) 3.4 1.1
Willingness to Continue - DVN (Week 5) - Yes 94.4 89.0
Willingness to Continue - DVN (Week 5) - No 0 1.1
A Little Bit Willing (Week 5) 5.6 4.4
Very Willing (Week 5) 88.8 84.6
A Little Unwilling (Week 5) 0 0
Very Unwilling (Week 5) 0 1.1
Benefit from Treatment - No benefit (Week 10) 4.5 3.3
Benefit from Treatment - Little benefit (Week 10) 14.6 9.9
Benefit from Treatment - Much benefit (Week 10) 71.9 70.3
Satisfaction from Treatment - DVN (Week 10) - Yes 83.1 80.2
Satisfaction from Treatment - DVN (Week 10) - No 7.9 3.3
A Little Satisfied (Week 10) 9.0 11.0
Very Satisfied (Week 10) 74.2 69.2
A Little Dissatisfied (Week 10) 5.6 2.2
Very Dissatisfied (Week 10) 2.2 1.1
Willingness to Continue - DVN (Week 10) - Yes 88.8 81.3
Willingness to Continue - DVN (Week 10) - No 2.2 2.2
A Little Bit Willing (Week 10) 4.5 4.4
Very Willing (Week 10) 84.3 76.9
A Little Unwilling (Week 10) 0 0
Very Unwilling (Week 10) 2.2 2.2
5.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
Hide Description The PGIC is a single-item, self-rated instrument that measures change in the patient’s overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.
Time Frame Week 5 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 5 (n=84, 82) 2.69  (0.11) 2.64  (0.11)
Week 10 (n=81, 76) 2.31  (0.10) 2.11  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Statistical analysis at Week 5 based on comparison between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7251
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.22 to 0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Statistical analysis at Week 10 based on comparison between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1255
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.06 to 0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)
Hide Description The PGIC is a single-item, self-rated instrument that measures change in the patient’s overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.
Time Frame Week 5 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Measure Type: Number
Unit of Measure: percentage of participants
Week 5 - very much improved(n=84, 82) 11.9 12.2
Week 5 - much worse(n=84, 82) 44.0 43.9
Week 5 - much improved(n=84, 82) 31.0 32.9
Week 5 - minimally improved(n=84, 82) 8.3 9.8
Week 5 - no change(n=84, 82) 4.8 1.2
Week 5 - minimally worse(n=84, 82) 0.0 0.0
Week 5 - very much worse(n=84, 82) 0.0 0.0
Week 5 - missing(n=84, 82) 0.0 0.0
Week 10 - very much improved(n=81, 76) 25.9 31.6
Week 10 - much improved(n=81, 76) 46.9 51.3
Week 10 - minimally improved(n=81, 76) 21.0 15.8
Week 10 - no change(n=81, 76) 4.9 0.0
Week 10 - minimally worse(n=81, 76) 0.0 1.3
Week 10 - much worse(n=81, 76) 1.2 0.0
Week 10 - very much worse(n=81, 76) 0.0 0.0
Week 10 - missing(n=81, 76) 0.0 0.0
7.Secondary Outcome
Title Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)
Hide Description The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 (“pain does not interfere with sleep”) to 10 ("pain completely interferes with sleep" [unable to sleep due to pain]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents ‘does not interfere with sleep’ and 10 represents ‘completely interferes’ which means you are unable to sleep due to pain.
Time Frame Week 5 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 5(n= 85, 79) -2.46  (0.235) -2.12  (0.236)
Week 10(n=81, 75) -3.69  (0.265) -3.38  (0.268)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Statistical analysis at Week 5 compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2856
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.97 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.317
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Statistical analysis at Week 10 compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3987
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-1.02 to 0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.363
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
Hide Description The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety.
Time Frame Week 5 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 5 (n=84, 82) -2.23  (3.78) -1.91  (3.23)
Week 10 (n=81, 76) -3.09  (4.34) -2.68  (4.08)
9.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)
Hide Description The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression.
Time Frame Week 5 and Week 10
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The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
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During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 5 (n=84, 82) -1.87  (4.18) -1.35  (3.87)
Week 10 (n=81, 76) -2.57  (4.62) -2.01  (3.84)
10.Secondary Outcome
Title Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2
Hide Description Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Time Frame Period 1 and Period 2
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The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
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During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Mean (Standard Deviation)
Unit of Measure: % of days
Period 1 (n=88, 90) (Mild) 19.1  (27.88) 15.3  (28.13)
Period 2 (n=84, 81) (Mild) 33.5  (36.98) 25.0  (34.50)
Period 1 (n=88, 90) (Moderate) 40.2  (34.07) 37.6  (35.23)
Period 2 (n=84, 81) (Moderate) 33.2  (34.28) 44.2  (39.41)
Period 1 (n=88, 90) (Severe) 38.8  (40.11) 44.8  (40.76)
Period 2 (n=84, 81) (Severe) 26.5  (39.09) 21.8  (34.91)
11.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10
Hide Description BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its ’worst,’ ’least,’ ’average,’ and ’now’ (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity.
Time Frame Week 5 and Week 10
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The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
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During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 5 (n=84, 82) -1.75  (2.07) -1.68  (1.86)
Week 10 (n=81, 76) -2.83  (2.26) -2.99  (2.45)
12.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10
Hide Description The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement.
Time Frame Week 5 and Week 10
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The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
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During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 89 91
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 5 (n= 84, 82) -21.3  (29.73) -16.5  (25.92)
Week 10 (n= 81, 76) -27.1  (25.70) -22.8  (25.04)
13.Secondary Outcome
Title Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
Hide Description The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame Week 5 and Week 10
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Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 88 90
Measure Type: Number
Unit of Measure: Percentage of participants
Yes (Week 5) 51.1 35.6
No (Week 5) 48.9 64.4
Yes (Week 10) 63.6 58.9
No (Week 10) 31.8 31.1
14.Secondary Outcome
Title Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10
Hide Description The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
Time Frame Week 5 and Week 10
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Hide Analysis Population Description
The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
Overall Number of Participants Analyzed 88 90
Measure Type: Number
Unit of Measure: Percentage of participants
Yes (Week 5) 25.0 20.0
No (Week 5) 75.0 80.0
Yes (Week 10) 42.0 37.8
No (Week 10) 53.4 52.2
Time Frame Adverse events were reported from the signing of the informed consent throughout the study period including 28 calendar days after the last dose of study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment. During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/89 (0.00%)      2/91 (2.20%)    
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/89 (0.00%)  0 2/91 (2.20%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/89 (31.46%)      19/91 (20.88%)    
Nervous system disorders     
Dizziness * 1  12/89 (13.48%)  12/91 (13.19%) 
Headache * 1  10/89 (11.24%)  7/91 (7.69%) 
Somnolence * 1  12/89 (13.48%)  7/91 (7.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
The study was terminated as it had been determined that it was no longer operationally feasible to continue the trial. The study termination was not due to a safety issue or finding.
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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01838044     History of Changes
Other Study ID Numbers: A0081296
First Submitted: April 15, 2013
First Posted: April 23, 2013
Results First Submitted: May 12, 2016
Results First Posted: September 1, 2016
Last Update Posted: September 1, 2016