Clinical Trial Results:
A Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile idiopathic arthritis
Summary
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EudraCT number |
2014-003737-26 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
17 Dec 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
04 May 2016
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First version publication date |
01 Aug 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A3191342
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00807846 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pfizer Inc
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 May 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Dec 2012
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the effect of treatment with celecoxib on systolic blood pressure (SBP) compared to treatment with naproxen in subjects with juvenile idiopathic arthritis (JIA) (oligoarticular, polyarticular arthritis and children with systemic onset disease but inactive systemic features).
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Sep 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Russian Federation: 21
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Country: Number of subjects enrolled |
Peru: 21
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Country: Number of subjects enrolled |
Philippines: 18
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Country: Number of subjects enrolled |
South Africa: 3
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Country: Number of subjects enrolled |
Ukraine: 27
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Country: Number of subjects enrolled |
Serbia: 29
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Country: Number of subjects enrolled |
Costa Rica: 2
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Country: Number of subjects enrolled |
United States: 66
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Country: Number of subjects enrolled |
Chile: 8
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Country: Number of subjects enrolled |
Switzerland: 3
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Worldwide total number of subjects |
198
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
96
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Adolescents (12-17 years) |
102
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This was a phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial in subjects with JIA. A total of 221 subjects were screened into the study in 32 investigator sites. | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 101 subjects were randomized to treatment with Celecoxib and 100 subjects to treatment with Naproxen. Of these randomized, 100 subjects received treatment with Celecoxib and 98 subjects received treatment with Naproxen. Three subjects were randomized but did not receive any treatment. | |||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Assessor | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Celecoxib | |||||||||||||||||||||||||||
Arm description |
Subjects received celecoxib for 6 weeks. The volume per (/) dose of the study medications was determined by the subject’s weight at baseline visit. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Celecoxib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received celecoxib capsules 50 millligram (mg) twice daily (BID) or 100 mg BID for 6 weeks.
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Arm title
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Naproxen | |||||||||||||||||||||||||||
Arm description |
Subjects received naproxen for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at baseline visit. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Naproxen
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received naproxen suspension 7.5 mg/kilogram (kg) BID (maximum dose of 500 mg BID) for 6 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Celecoxib
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Reporting group description |
Subjects received celecoxib for 6 weeks. The volume per (/) dose of the study medications was determined by the subject’s weight at baseline visit. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Naproxen
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Reporting group description |
Subjects received naproxen for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at baseline visit. | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Celecoxib
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Reporting group description |
Subjects received celecoxib for 6 weeks. The volume per (/) dose of the study medications was determined by the subject’s weight at baseline visit. | ||
Reporting group title |
Naproxen
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Reporting group description |
Subjects received naproxen for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at baseline visit. |
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End point title |
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit | ||||||||||||
End point description |
Value at 6 weeks minus value at baseline. Safety population included all randomized subjects 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.
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End point type |
Primary
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End point timeframe |
6 Weeks/Final Visit
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Statistical analysis title |
Change from baseline in SBP at Week 6/Final Visit | ||||||||||||
Statistical analysis description |
The primary analysis was based on 90 percentage (%) 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.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.274 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
1.1
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
-0.56 | ||||||||||||
upper limit |
2.76 |
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End point title |
Change From Baseline to Week 2 in SBP | ||||||||||||
End point description |
Value at 2 weeks minus value at baseline. Safety population included all randomized subjects 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.
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End point type |
Secondary
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End point timeframe |
2 weeks
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Statistical analysis title |
Change from baseline in SBP at Week 2 | ||||||||||||
Statistical analysis description |
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.
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Comparison groups |
Naproxen v Celecoxib
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Number of subjects included in analysis |
194
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.148 [1] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
1.088
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.39 | ||||||||||||
upper limit |
2.57 | ||||||||||||
Notes [1] - Secondary analyses were conducted using a two-sided test with α=0.05. |
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End point title |
Change From Baseline in SBP at Week 4 | ||||||||||||
End point description |
Value at 4 weeks minus value at baseline. Safety population included all randomized subjects 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.
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End point type |
Secondary
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End point timeframe |
4 weeks
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Statistical analysis title |
Change from baseline in SBP at Week 4 | ||||||||||||
Statistical analysis description |
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.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.027 [2] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
1.837
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.21 | ||||||||||||
upper limit |
3.46 | ||||||||||||
Notes [2] - Secondary analyses were conducted using a two-sided test with α=0.05. |
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End point title |
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2 | ||||||||||||
End point description |
Value at 2 weeks minus value at baseline. Safety population included all randomized subjects 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.
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End point type |
Secondary
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End point timeframe |
2 weeks
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Statistical analysis title |
Change from baseline in DBP at Week 2 | ||||||||||||
Statistical analysis description |
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.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
194
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.106 [3] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-1.207
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.67 | ||||||||||||
upper limit |
0.26 | ||||||||||||
Notes [3] - Secondary analyses were conducted using a two-sided test with α=0.05. |
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End point title |
Change From Baseline in DBP at Week 4 | ||||||||||||
End point description |
Value at 4 weeks minus value at baseline. Safety population included all randomized subjects 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.
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End point type |
Secondary
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End point timeframe |
4 weeks
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Statistical analysis title |
Change from baseline in DBP at Week 4 | ||||||||||||
Statistical analysis description |
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.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.776 [4] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.22
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.3 | ||||||||||||
upper limit |
1.74 | ||||||||||||
Notes [4] - Secondary analyses were conducted using a two-sided test with α=0.05. |
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End point title |
Change From Baseline in DBP at Week 6/Final Visit | ||||||||||||
End point description |
Value at 6 weeks/Final Visit minus value at baseline. Safety population included all randomized subjects 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.
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End point type |
Secondary
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End point timeframe |
6 weeks
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Statistical analysis title |
Change from baseline in DBP at Week 6 | ||||||||||||
Statistical analysis description |
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.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
196
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.815 [5] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.179
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.69 | ||||||||||||
upper limit |
1.33 | ||||||||||||
Notes [5] - Secondary analyses were conducted using a two-sided test with α=0.05. |
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End point title |
Change From Baseline in Parent's Assessment of Overall Well-Being at Week 6/Final Visit | ||||||||||||
End point description |
The parent/legal guardian evaluated the subject'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. Modified-Intent-to-Treat (MITT) Population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline efficacy measurement.
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End point type |
Secondary
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End point timeframe |
6 weeks
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Statistical analysis title |
Parent's assessment of overall well-being | ||||||||||||
Statistical analysis description |
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.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
194
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.303 [6] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
3.033
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.76 | ||||||||||||
upper limit |
8.82 | ||||||||||||
Notes [6] - This analysis was conducted using a two-sided test with α=0.05. |
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End point title |
Number of Subjects with >= 30% Improvement in the Parent’s Global Assessment of Overall Well-Being at Week 6/Final Visit | |||||||||
End point description |
The parent/legal guardian evaluated the subject'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. The MITT Population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline efficacy measurement.
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End point type |
Secondary
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End point timeframe |
Week 6/Final Visit
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Statistical analysis title |
Parent’s global assessment of overall well-being | |||||||||
Statistical analysis description |
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. Mean Difference (Final Values) indicates difference in incidence between treatments.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
194
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.392 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
-0.061
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
-0.202 | |||||||||
upper limit |
0.079 |
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End point title |
Change From Baseline in Subject's Assessment of Overall Well-Being at Week 6/Final Visit | ||||||||||||
End point description |
Subjects, >= 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’. MITT population was used. Additional 3 subjects aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 subjects (>=8 yrs) did not provide self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 subject (<8 yrs) provided self-assessment and was included in analysis.
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End point type |
Secondary
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End point timeframe |
6 weeks
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Statistical analysis title |
Subject's assessment of overall well-being | ||||||||||||
Statistical analysis description |
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.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
158
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.897 [7] | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.402
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-6.5 | ||||||||||||
upper limit |
5.69 | ||||||||||||
Notes [7] - This analysis was conducted using a two-sided test with α=0.05. |
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End point title |
Number of Subjects with >= 30% Improvement in the Subject's Global Assessment of Overall Well-Being at Week 6/Final Visit | |||||||||
End point description |
Subjects, >=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’. MITT population was used. Additional 3 subjects aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 subjects (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 subject (<8 yrs) provided self-assessment and included in analysis.
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End point type |
Secondary
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End point timeframe |
Week 6/Final Visit
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Statistical analysis title |
Subject's global assessment of overall well-being | |||||||||
Statistical analysis description |
The number of subjects with at least a 30% improvement in subject'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. Mean Difference (Final Values) indicates difference in incidence between treatments.
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Comparison groups |
Celecoxib v Naproxen
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Number of subjects included in analysis |
158
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
= 0.2 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
-0.102
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-0.257 | |||||||||
upper limit |
0.053 |
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End point title |
Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit | ||||||||||||||||||
End point description |
Ambulatory BP measurements were obtained from 24 subjects (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. Safety population included all randomized subjects who received at least one dose of study medication. For one subject in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this subject was not included in analysis. ABPM data were analyzed for 12 and 11 subjects in Celecoxib and Naproxen Arms respectively.
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End point type |
Other pre-specified
|
||||||||||||||||||
End point timeframe |
6 weeks/Final Visit
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit | ||||||||||||
End point description |
Ambulatory BP measurements were obtained from 24 subjects (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. Safety population included all randomized subjects who received at least one dose of study medication. For one subject in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this subject was not included in analysis. ABPM data were analyzed for 12 and 11 subjects in Celecoxib and Naproxen Arms respectively.
|
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End point type |
Other pre-specified
|
||||||||||||
End point timeframe |
6 weeks/Final Visit
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Up to Week 6/Final Visit
|
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Adverse event reporting additional 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.
|
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
|
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Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Celecoxib
|
|||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received celecoxib for 6 weeks. The volume per (/) dose of the study medications was determined by the subject’s weight at baseline visit | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Naproxen
|
|||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received naproxen for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at baseline visit | |||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
14 Apr 2009 |
1. To correct and extend information given on the volume per dose naproxen/placebo in reference to body weight. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |