Full Text View
Tabular View
No Study Results Posted
Related Studies
Meloxicam Suspension in Juvenile Rheumatoid Arthritis (JRA)
This study has been completed.
Study NCT00034853   Information provided by Boehringer Ingelheim Pharmaceuticals
First Received: May 2, 2002   Last Updated: March 27, 2006   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

May 2, 2002
March 27, 2006
December 2000
 
 
Complete list of historical versions of study NCT00034853 on ClinicalTrials.gov Archive Site
 
 
 
Meloxicam Suspension in Juvenile Rheumatoid Arthritis (JRA)
A 12 Wk Double-Blind Randomized Trial, With a 12 Wk Open-Label Extension, to Investigate Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With JRA.

The purpose of this 6 month study is to determine how safe and effective meloxicam oral suspension (liquid taken by mouth) is in children with JRA.

The primary aim of this trial is to compare the efficacy and safety of several doses of meloxicam oral suspension (0.125 mg/kg and 0.25 mg/kg with a 0.125 mg/kg dose escalation at 4 weeks) administered once daily with naproxen oral suspension (10 mg/kg with a dose escalation to15 mg/kg at 4 weeks administered in divided doses twice daily) over a period of 12 weeks in the treatment of patients with JRA. The 12-week double-blind portion of the trial is followed by an open-label extension of meloxicam oral suspension at 0.375 mg/kg/day to obtain additional safety information. A subgroup of patients will participate in a pharmacokinetic study at the conclusion of the open label extension phase.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Juvenile Rheumatoid Arthritis
Drug: Meloxicam
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
180
June 2003
 

Inclusion Criteria:

  • Males or females 2-17 years old.
  • Diagnosis of JRA for at least 6 weeks, onset of disease less than 16 years old.
  • Current course of disease pauciarthritic, extended pauciarthritic, or polyarthritic.
  • Active arthritis of at least 2 joints.
  • Patient requires therapy with an NSAID.
  • At screening, patient has at least 2 abnormal variables among the following: CHAQ, ESR, Investigator’s Assessment of Overall Disease Activity, or Parent’s Assessment of Overall Well-Being.

Exclusion Criteria:

  • Systemic course of JRA
  • Weight less than 9kg
  • History of bleeding disorders, gastrointestinal bleeding, peptic ulcer, cerebrovascular bleeding, rheumatic conditions other than JRA, or any disease that could interfere with the trial or the child’s safety.
Both
2 Years to 17 Years
No
 
United States,   Argentina,   Brazil,   Mexico
 
 
NCT00034853
 
 
Boehringer Ingelheim Pharmaceuticals
 
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
September 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.