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

This study has been completed.

First Received: January 9, 2006 Last Updated: August 28, 2008 History of Changes

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

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)

Resource links provided by NLM:

MedlinePlus related topics: Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Naproxen Naproxen sodium Meloxicam

U.S. FDA Resources

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Naproxen
Joint Diseases
Cyclooxygenase Inhibitors
Meloxicam
Arthritis, Rheumatoid
Rheumatic Diseases

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Arthritis, Rheumatoid
Gout Suppressants
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Naproxen

Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Immune System Diseases
Joint Diseases
Meloxicam
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 06, 2009