A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)
NCT00279747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226
Last updated 2013-11-01
Summary
A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.
Conditions
- Arthritis, Juvenile Rheumatoid
Interventions
- DRUG
-
meloxicam 0.25 mg/kg
- DRUG
-
meloxicam 0.125 mg/kg
- DRUG
-
naproxen 10 mg/kg
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim Study Coordinator · B.I. Pharma GmbH & Co. KG
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-09-30
- Primary Completion
- 2003-01-31
- Completion
- 2003-01-31
Countries
- Austria
- Belgium
- France
- Germany
- Italy
- Russia
- United Kingdom
Study Locations
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