Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid...
Date First Received: January 9, 2006
Last Updated: June 25, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, June 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2000
Overall Status: Completed
Estimated Enrollment: 180
Brief Summary
Official Title: “Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208)”
Condition Keyword(s):
Intervention(s):
Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Outcome Measures for this Clinical Trial
Primary:
- 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:
- 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)
Criteria for Participation in this Clinical Trial
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Boehringer Ingelheim Pharmaceuticals
Arkansas Children's Hospital
Little Rock Arkansas United States
Attn: Kathy Schilling
Madera California United States
Boehringer Ingelheim Investigational Site
San Diego California United States
Connecticut Children's Medical Center
Hartford Connecticut United States
Attn: Denise Axsmith, Financial Analyst
Wilmington Delaware United States
Miami Children's Hospital
Miami Florida United States
Boehringer Ingelheim Investigational Site
Del Ray Beach Florida United States
Clinical Research Dept #7006
St. Petersberg Florida United States
Attn: Philip Soina, CRA
Chicago Illinois United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City Kansas United States
University of Louisville
Louisville Kentucky United States
Children's Hospital - Department of Rheumatology
New Orleans Louisiana United States
Deparment of Rheumatology
Boston Massachusetts United States
Mayo Clinic
Rochester Minnesota United States
St. Louis University
St. Louis Missouri United States
Washington University School of Medicine
St. Louis Missouri United States
Attn: David Clouthier
Omaha Nebraska United States
Boehringer Ingelheim Investigational Site
Livingston New Jersey United States
Columbia University
New York New York United States
The Children's Hospital of Buffalo
Buffalo New York United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma United States
Boehringer Ingelheim Investigational Site
Tulsa Oklahoma United States
Boehringer Ingelheim Investigational Site
Duncansville Pennsylvania United States
Division of Ambulatory Pediatrics
Providence Rhode Island United States
Texas Scottish Rite Hospital
Dallas Texas United States
Boehringer Ingelheim Investigational Site
Salt LAke City Utah United States
Children's Hospital
Seattle Washington United States
Medical College of Wisconsin
Milwaukee Wisconsin United States
Boehringer Ingelheim Investigational Site
Sao Paulo Brazil
Instituto de Crianca / Hospital das Clínicas-FMUSP
Mooca / São Paulo Brazil
Boehringer Ingelheim Investigational Site
Santa Cecília Brazil
Boehringer Ingelheim Investigational Site
México, D.F. Mexico
Children Clinical Hospital No. 1
Kiev Ukraine
Institute of Children and Adolescents Health
Kharkov Ukraine
Institute of Pediatrics
Kiev Ukraine
2nd Children Specialized Clinical Hospital "OHMADIT"
Kiev Ukraine
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00274482
Study ID Number: 107.235
ClinicalTrials.gov Identifier: NCT00274482
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
