Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid...
Date First Received: January 9, 2006
Last Updated: August 28, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, June 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2000
Overall Status: Completed
Estimated Enrollment: 180
Brief Summary
Official Title: “Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208)”
Condition Keyword(s):
Intervention(s):
Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Intervention(s) in this Clinical Trial
- Drug: meloxicam oral suspension
- Drug: naproxen oral suspension
Outcome Measures for this Clinical Trial
Primary Measures
- ACR Pediatric 30 (composite endpoint) at 12 weeks (end of double blind treatment period): invest. global assessment of dis. act. parent global assessment of overalll well-being, no. of active and swollen jts, functional disability index (CHAQ), ESR.
Secondary Measures
- Each of the individual core set outcome criteria that makes up the ACR Ped 30, investigator and parent global assessment of efficacy, withdrawals due to inadequate efficacy and acetaminophen consumption (rescue medication)
Criteria for Participation in this Clinical Trial
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 2 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Boehringer Ingelheim Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00274482
Study ID Number: 107.235
ClinicalTrials.gov Identifier: NCT00274482
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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