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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00807846
First received: December 10, 2008
Last updated: October 7, 2015
Last verified: October 2015
Results First Received: December 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Juvenile Rheumatoid
Interventions: Drug: Celecoxib
Drug: Naproxen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Celecoxib 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
Naproxen 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

Participant Flow:   Overall Study
    Celecoxib     Naproxen  
STARTED     100     98  
COMPLETED     88     94  
NOT COMPLETED     12     4  
Adverse Event                 5                 0  
Lack of Efficacy                 2                 0  
Protocol Violation                 2                 1  
Withdrawal by Subject                 2                 1  
Not Specified                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Celecoxib 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
Naproxen 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 Total of all reporting groups

Baseline Measures
    Celecoxib     Naproxen     Total  
Number of Participants  
[units: participants]
  100     98     198  
Age, Customized  
[units: Participants]
     
>=2 - <8 Years     22     18     40  
>=8 - <13 Years     34     47     81  
>=13 - <18 Years     44     33     77  
Gender  
[units: Participants]
     
Female     76     64     140  
Male     24     34     58  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit   [ Time Frame: 6 Weeks/Final Visit ]

2.  Secondary:   Change From Baseline to Week 2 in SBP.   [ Time Frame: 2 weeks ]

3.  Secondary:   Change From Baseline in SBP at Week 4.   [ Time Frame: 4 weeks ]

4.  Secondary:   Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.   [ Time Frame: 2 weeks ]

5.  Secondary:   Change From Baseline in DBP at Week 4.   [ Time Frame: 4 weeks ]

6.  Secondary:   Change From Baseline in DBP at Week 6/Final Visit   [ Time Frame: 6 weeks ]

7.  Secondary:   Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.   [ Time Frame: 6 weeks ]

8.  Secondary:   Number of Participants With >= 30% Improvement in the Parent’s Global Assessment of Overall Well-being at Week 6/Final Visit.   [ Time Frame: Week 6/Final Visit ]

9.  Secondary:   Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.   [ Time Frame: 6 weeks ]

10.  Secondary:   Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.   [ Time Frame: Week 6/Final Visit ]

11.  Other Pre-specified:   Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit   [ Time Frame: 6 weeks/Final Visit ]

12.  Other Pre-specified:   Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit   [ Time Frame: 6 weeks/Final Visit ]

13.  Other Pre-specified:   Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)   [ Time Frame: 6 weeks/Final Visit ]

14.  Other Pre-specified:   Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)   [ Time Frame: 6 weeks/Final Visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00807846     History of Changes
Other Study ID Numbers: A3191342
Study First Received: December 10, 2008
Results First Received: December 12, 2013
Last Updated: October 7, 2015
Health Authority: United States: Food and Drug Administration