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	Treatment or Intervention	Phase
Juvenile Rheumatoid Arthritis	Drug: Meloxicam	Phase III

Further Study Details: 

Expected Total Enrollment:  180

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.

Ages Eligible for Study:  2 Years   -   17 Years,  Genders Eligible for Study:  Both

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.

Arkansas
      Arkansas Children's Hospital, Little Rock,  Arkansas,  72202,  United States
California
      Valley Children's Hospital, Rheumatology Dept., Madera,  California,  93738,  United States
      Children's Hospital Research Clinic, San Diego,  California,  92123,  United States
Colorado
      Children's Hospital, Denver,  Colorado,  80218,  United States
Florida
      Miami Children's Hospital, Miami,  Florida,  33155,  United States
      Arthritis Association Clinical Research of So. Florida, Delray Beach,  Florida,  33484,  United States
      All Children's Hospital, St. Petersburg,  Florida,  33701,  United States
Kentucky
      University of Louisville, Dept. of Pediatrics, Louisville,  Kentucky,  40202,  United States
Louisiana
      Children's Hospital, Dept. of Rheumatology, New Orleans,  Louisiana,  70118,  United States
Massachusetts
      Children's Hospital Medical Center, Dept. of Rheumatology, Boston,  Massachusetts,  02115,  United States
Minnesota
      E15 Mayo Clinic, Rochester,  Minnesota,  55905,  United States
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States
Nebraska
      Creighton University, Dept. of Pediatrics, Omaha,  Nebraska,  68178,  United States
New Jersey
      Arthritis and Rheumatic Disease Center, Livingston,  New Jersey,  07039,  United States
New York
      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States
      The Children's Hospital of Buffalo, Div. of Allergy, Immunology and Rheumatology, Buffalo,  New York,  14222,  United States
Oklahoma
      Oklahoma Medical Research Foundation, Div. of Rheumatology, Oklahoma City,  Oklahoma,  73104,  United States
      HealthCare Research Consultants, Tulsa,  Oklahoma,  74135,  United States
Pennsylvania
      Arthritis and Osteoporosis Center, Duncansville,  Pennsylvania,  16635,  United States
Rhode Island
      Div. of Ambulatory Pediatrics, Hasbro Children's Hospital, Providence,  Rhode Island,  02903,  United States
Texas
      Texas Scottish Rite Hospital, Dept. of Pediatric Rheumatology, Dallas,  Texas,  75219,  United States
Utah
      University of Utah School of Medicine, Dept. of Pediatrics, Salt Lake City,  Utah,  84132,  United States
Washington
      Children's Hospital, Pediatric Rheumatology, Seattle,  Washington,  98105,  United States
Wisconsin
      Medical College of Wisconsin, Dept. of Pediatrics, Milwaukee,  Wisconsin,  53226,  United States
Argentina
      Hospital de Ninos, Buenos Aires,  01430,  Argentina
Brazil
      Epm Universidade Federal de Sao Paulo, Sao Paulo,  04025,  Brazil
Mexico
      Hospital General de Mexico, Mexico City,  06726,  Mexico

Study ID Numbers:  BI 107.235
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00034853
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08