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Trial record 20 of 690 for:    Russian Federation | Chile

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 12, 2008
Results First Submitted Date  ICMJE December 12, 2013
Results First Posted Date  ICMJE November 11, 2015
Last Update Posted Date November 11, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit [ Time Frame: 6 Weeks/Final Visit ]
Value at 6 weeks minus value at baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
The primary objective of the study is to evaluate the effect of treatment with celecoxib on systolic BP (SBP) compared to treatment with naproxen in subjects with Juvenile Idiopathic Arthritis [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Change From Baseline to Week 2 in SBP. [ Time Frame: 2 weeks ]
    Value at 2 weeks minus value at baseline.
  • Change From Baseline in SBP at Week 4. [ Time Frame: 4 weeks ]
    Value at 4 weeks minus value at baseline.
  • Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. [ Time Frame: 2 weeks ]
    Value at 2 weeks minus value at baseline.
  • Change From Baseline in DBP at Week 4. [ Time Frame: 4 weeks ]
    Value at 4 weeks minus value at baseline.
  • Change From Baseline in DBP at Week 6/Final Visit [ Time Frame: 6 weeks ]
    Value at 6 weeks/Final Visit minus value at baseline.
  • Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit. [ Time Frame: 6 weeks ]
    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.
  • 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 ]
    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.
  • Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. [ Time Frame: 6 weeks ]
    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'.
  • 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 ]
    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'.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
  • Effect of treatment with celecoxib on diastolic BP (DBP) compared to treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ]
  • Adverse event profile and GI tolerability of treatment with celecoxib vs. treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ]
  • Effect of treatment with celecoxib on Parent's and Subject's Global Assessment of Overall Well-Being compared to treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ]
  • Effect of celecoxib and naproxen on blood pressure measured by Ambulatory Blood Pressure Monitoring (ABPM) in subjects with JIA [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: October 7, 2015)
  • 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 ]
    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.
  • Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit [ Time Frame: 6 weeks/Final Visit ]
    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.
  • 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 ]
    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).
  • 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 ]
    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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Official Title  ICMJE 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 Pediatric Subjects With Juvenile Idiopathic Arthritis.
Brief Summary This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Juvenile Rheumatoid
Intervention  ICMJE
  • Drug: Celecoxib
    Celecoxib 50 mg or 100 mg PO BID for 6 weeks
  • Drug: Naproxen
    Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
Study Arms  ICMJE
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
  • Experimental: Naproxen
    Intervention: Drug: Naproxen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)
201
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2008)
200
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
  • Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
  • ≥2 years of age and <18 years of age prior to the Baseline visit
  • Body weight ≥10 kg at the Baseline visit
  • Candidate for chronic NSAID therapy in the Investigator's judgment

Exclusion Criteria:

  • Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
  • Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
  • Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
  • Subjects with active Systemic JIA should not be enrolled
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Costa Rica,   Peru,   Philippines,   Serbia,   South Africa,   Switzerland,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807846
Other Study ID Numbers  ICMJE A3191342
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP