Meloxicam Suspension in Juvenile Rheumatoid Arthritis (JRA) - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00034853

Purpose

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.

Condition	Intervention	Phase
Juvenile Rheumatoid Arthritis	Drug: Meloxicam	Phase III

MedlinePlus related topics: Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Naproxen Naproxen sodium Meloxicam

U.S. FDA Resources

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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment:	180
Study Start Date:	December 2000
Estimated Study Completion Date:	June 2003

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034853

Show 27 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Study ID Numbers:	BI 107.235
Study First Received:	May 2, 2002
Last Updated:	March 27, 2006
ClinicalTrials.gov Identifier:	NCT00034853
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 January 16, 2009