Clinical Trial: Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension A

Brief Summary: To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: Responder rate by core set of outcome criteria (Juvenile Rheumatoid Arthritis Pediatric 30): global assessment disease activity; functional disability, number joints arthritis, limited motion; erythrocyte sedimentation rate; [ Time Frame: week 12 ]

Original Primary Outcome:

Current Secondary Outcome: Individual core set outcome criteria; final global assessment of efficacy; tolerability; AE incidence and intensity; withdrawals; acetaminophen consumption; safety labs: physical examination; hospitalization for gastrointestinal (GI) SAE, GI AE [ Time Frame: weeks 4, 8, 12, 18, and 24 ]

Original Secondary Outcome:

Information By: Boehringer Ingelheim

Dates:
Date Received: May 2, 2002
Date Started: December 2000
Date Completion:
Last Updated: October 31, 2013
Last Verified: October 2013