Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Purpose
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

Condition Intervention Phase
Arthritis, Juvenile Rheumatoid
Drug: Celecoxib
Drug: Naproxen
Phase 4

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
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit [ Time Frame: 6 Weeks/Final Visit ] [ Designated as safety issue: Yes ]
    Value at 6 weeks minus value at baseline.


Secondary Outcome Measures:
  • Change From Baseline to Week 2 in SBP. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Value at 2 weeks minus value at baseline.

  • Change From Baseline in SBP at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Value at 4 weeks minus value at baseline.

  • Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Value at 2 weeks minus value at baseline.

  • Change From Baseline in DBP at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Value at 4 weeks minus value at baseline.

  • Change From Baseline in DBP at Week 6/Final Visit [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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'.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 201
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib Drug: Celecoxib
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
Experimental: Naproxen Drug: Naproxen
Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807846

  Show 39 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

Keywords provided by Pfizer:
Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Celecoxib
Naproxen
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants

ClinicalTrials.gov processed this record on September 30, 2016