Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Meloxicam

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00034853

Study ID Number: BI 107.235

ClinicalTrials.gov Identifier: NCT00034853

Health Authority: United States: Food and Drug Administration