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Trial record 20 of 647 for:    Russian Federation | Chile

A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects

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ClinicalTrials.gov Identifier: NCT00807846
Recruitment Status : Completed
First Posted : December 12, 2008
Results First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Juvenile Rheumatoid
Interventions Drug: Celecoxib
Drug: Naproxen
Enrollment 201
Recruitment Details This was a phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial in participants with juvenile idiopathic arthritis (JIA). A total of 221 participants were screened into the study in 32 investigator sites.
Pre-assignment Details A total of 101 participants were randomized to treatment with Celecoxib and 100 participants to treatment with Naproxen. Of these randomized, 100 participants received treatment with Celecoxib and 98 participants received treatment with Naproxen. Three participants were randomized but did not receive any treatment.
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Period Title: Overall Study
Started 100 98
Completed 88 94
Not Completed 12 4
Reason Not Completed
Adverse Event             5             0
Lack of Efficacy             2             0
Protocol Violation             2             1
Withdrawal by Subject             2             1
Not Specified             1             2
Arm/Group Title Celecoxib Naproxen Total
Hide Arm/Group Description Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit Total of all reporting groups
Overall Number of Baseline Participants 100 98 198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 98 participants 198 participants
>=2 - <8 Years 22 18 40
>=8 - <13 Years 34 47 81
>=13 - <18 Years 44 33 77
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 98 participants 198 participants
Female
76
  76.0%
64
  65.3%
140
  70.7%
Male
24
  24.0%
34
  34.7%
58
  29.3%
1.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Hide Description Value at 6 weeks minus value at baseline.
Time Frame 6 Weeks/Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP (blood pressure) measurements.

For early terminations the last observation carried forward (LOCF) was used to impute missing data.

Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 100 98
Least Squares Mean (Standard Error)
Unit of Measure: mmHg (millimeter of mercury)
0.366  (0.70) -0.734  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib – naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.274
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.100
Confidence Interval (2-Sided) 90%
-0.56 to 2.76
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 2 in SBP.
Hide Description Value at 2 weeks minus value at baseline.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 100 98
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.202  (0.53) -1.290  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.088
Confidence Interval (2-Sided) 95%
-0.39 to 2.57
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in SBP at Week 4.
Hide Description Value at 4 weeks minus value at baseline.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 100 98
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.170  (0.58) -2.007  (0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments

For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.

Secondary analyses were conducted using a two-sided test with α=0.05.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.837
Confidence Interval (2-Sided) 95%
0.21 to 3.46
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
Hide Description Value at 2 weeks minus value at baseline.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 100 98
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-1.346  (0.52) -0.139  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.106
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.207
Confidence Interval (2-Sided) 95%
-2.67 to 0.26
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in DBP at Week 4.
Hide Description Value at 4 weeks minus value at baseline.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 100 98
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.628  (0.54) -0.848  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.776
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.220
Confidence Interval (2-Sided) 95%
-1.30 to 1.74
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in DBP at Week 6/Final Visit
Hide Description Value at 6 weeks/Final Visit minus value at baseline.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 100 98
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.535  (0.54) -0.356  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.815
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.179
Confidence Interval (2-Sided) 95%
-1.69 to 1.33
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
Hide Description The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified-Intent-to-Treat (MITT) Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 98 98
Least Squares Mean (Standard Error)
Unit of Measure: mm (millimeter)
-10.581  (2.081) -13.614  (2.060)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.033
Confidence Interval (2-Sided) 95%
-2.76 to 8.82
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With >= 30% Improvement in the Parent’s Global Assessment of Overall Well-being at Week 6/Final Visit.
Hide Description The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor.
Time Frame Week 6/Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 98 98
Measure Type: Number
Unit of Measure: Participants
47 54
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.392
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.061
Confidence Interval (2-Sided) 95%
-0.202 to 0.079
Estimation Comments Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.
9.Secondary Outcome
Title Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
Hide Description Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 75 83
Least Squares Mean (Standard Error)
Unit of Measure: mm
-12.990  (2.226) -12.588  (2.115)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.897
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.402
Confidence Interval (2-Sided) 95%
-6.50 to 5.69
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
Hide Description Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’.
Time Frame Week 6/Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 75 83
Measure Type: Number
Unit of Measure: Participants
33 45
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Naproxen
Comments The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.102
Confidence Interval (2-Sided) 95%
-0.257 to 0.053
Estimation Comments Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.
11.Other Pre-specified Outcome
Title Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit
Hide Description Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.
Time Frame 6 weeks/Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP 2.4  (7.02) -1.7  (12.40)
DBP 0.9  (4.23) -1.1  (5.36)
12.Other Pre-specified Outcome
Title Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit
Hide Description Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure.
Time Frame 6 weeks/Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: bpm (beats per minute)
2.5  (6.34) 3.7  (8.50)
13.Other Pre-specified Outcome
Title Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
Hide Description A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).
Time Frame 6 weeks/Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP 2.4  (7.02) 1.9  (4.13)
DBP 0.9  (4.23) 0.3  (2.86)
14.Other Pre-specified Outcome
Title Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
Hide Description A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).
Time Frame 6 weeks/Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description:
Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: bpm
2.5  (6.34) 3.3  (8.82)
Time Frame Up to Week 6/Final Visit
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Celecoxib Naproxen
Hide Arm/Group Description Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
All-Cause Mortality
Celecoxib Naproxen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib Naproxen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   1/98 (1.02%) 
Injury, poisoning and procedural complications     
Hand fracture * 1  0/100 (0.00%)  1/98 (1.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Celecoxib Naproxen
Affected / at Risk (%) Affected / at Risk (%)
Total   10/100 (10.00%)   18/98 (18.37%) 
Gastrointestinal disorders     
Nausea * 1  4/100 (4.00%)  9/98 (9.18%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/100 (1.00%)  5/98 (5.10%) 
Nervous system disorders     
Headache * 1  7/100 (7.00%)  4/98 (4.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
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 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
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.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00807846     History of Changes
Other Study ID Numbers: A3191342
First Submitted: December 10, 2008
First Posted: December 12, 2008
Results First Submitted: December 12, 2013
Results First Posted: November 11, 2015
Last Update Posted: November 11, 2015