A Study of Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA) - Full Text View

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

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

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