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A Study of Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

This study has been completed.

Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00274482
  Purpose

Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis


Condition Intervention Phase
Arthritis, Juvenile Rheumatoid
Drug: meloxicam oral suspension
Drug: naproxen oral suspension
Phase III

MedlinePlus related topics:   Juvenile Rheumatoid Arthritis    Rheumatoid Arthritis   

ChemIDplus related topics:   Naproxen    Meloxicam    Naproxen sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:   Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome 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 Outcome 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)

Estimated Enrollment:   180
Study Start Date:   November 2000
Estimated Study Completion Date:   May 2004

  Eligibility
Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274482

Show 36 study locations  Show 36 Study Locations

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals

Investigators
Study Chair:     Boehringer Ingelheim Study Coordinator     Boehringer Ingelheim Pharmaceuticals    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   107.235
First Received:   January 9, 2006
Last Updated:   August 28, 2008
ClinicalTrials.gov Identifier:   NCT00274482
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Naproxen
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Musculoskeletal Diseases
Joint Diseases
Arthritis
Meloxicam
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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