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A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)
This study has been completed.
First Received: January 19, 2006   Last Updated: October 7, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00279747
  Purpose

A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.


Condition Intervention Phase
Arthritis, Juvenile Rheumatoid
Drug: meloxicam 0.25 mg/kg
Drug: meloxicam 0.125 mg/kg
Drug: naproxen 10 mg/kg
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Response rates according to ACR Ped 30

Secondary Outcome Measures:
  • Investigator global assessment of overall disease activity, parent global assessment of overall well-being, number of joints with active arthritis, number of joints with limited range of motion, assessment of functional disability by means of CHAQ

Estimated Enrollment: 180
Study Start Date: September 2000
Estimated Study Completion Date: January 2003
Detailed Description:

Objective: In an international, multicenter, double-blind, randomized clinical trial we evaluated the short-term (3 months) and long term (12 months) efficacy and safety of two doses of meloxicam oral suspension compared with naproxen in children with oligo and polyarticular course juvenile idiopathic arthritis (JIA).

Methods: Children with active oligo or polyarticular course JIA, requiring therapy with an NSAID were eligible for this trial. Patients were randomly allocated to therapy with meloxicam oral suspension 0.125 mg/kg body weight in single daily dose, meloxicam 0.25 mg/kg body weight in single daily dose, or naproxen 10 mg/kg body weight in two daily doses. The trial drugs were administered in a double-blind, double-dummy design for up to 12 months. Response rates were determined according to the American College of Rheumatology Pediatric 30% definition of improvement (ACR Ped 30). Safety parameters were assessed by evaluation of the adverse events in the 3 groups.

Study Hypothesis:

The null hypothesis of interest is that the magnitude of response with regard to the primary endpoint is equivalent between the treatment groups. The alternative is that there is any difference (two-sided) between any of the treatment groups.

Comparison(s):

Naproxen oral suspension 10 mg/kg body weight.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatients and inpatients aged 2 to 16 years
  • Diagnosis of idiopathic arthritis of childhood by ILAR criteria:

    • Age of onset less than 16 years
    • Arthritis in one or more joints defined as swelling, or - if no swelling is present - limitation in range of joint movement with joint pain or tenderness, which is not due to primary mechanical disorders
    • Duration of the disease > 6 weeks
    • Type of onset of disease during the first 6 months classified as polyarthritis (5 joints or more; rheumatoid factor positive or negative), oligoarthritis (4 joints or fewer) or systemic arthritis
  • Oligoarthritic, extended oligoarthritic or polyarthritic current course of disease
  • Active arthritis as defined above of at least 2 joints
  • At least 2 other abnormal variables of any of the 5 remaining core set parameters. The physician and the parent ratings must be at least 10 mm on a 100 mm VAS scale and the CHAQ score more than 0.
  • Patients requiring therapy with NSAIDs, i.e., the patient fits into one of the following categories:

    • New onset patient
    • Patient in remission, but experiencing a flare and now requiring an NSAID
    • Patient with insufficient therapeutic effect (ITE) or intolerability to another NSAID (other than Naproxen) and now must be changed
  • Written informed permission given by the parent(s) or the subjects legally authorised representative in accordance with local legislation and ICH GCP
  • Active assent given by the patient if the child is capable of understanding the given information (applies to children who have reached an intellectual age of 7 years or greater)

Exclusion Criteria:

  • Patients with systemic course of JRA (intermittent fever with or without rash or other organ involvement) or with current systemic involvement
  • All rheumatic diseases not covered by the inclusion criteria
  • Any finding indicating that the patient has a clinically significant other disease than JRA at the time of enrollment
  • Patients with abnormal, clinically relevant laboratory values not related to their JRA
  • Pregnancy or breast feeding
  • Women of childbearing potential not using adequate contraception precaution: attention should be drawn to reports that NSAIDs were reported to decrease the effectiveness of intrauterine devices (R95-0164)
  • History of bleeding disorders, gastrointestinal bleeding or cerebrovascular bleeding
  • Active peptic ulcer within the last 6 months
  • Treatment with more than one SAARD/DMARD (slow-acting antirheumatic drug/disease-modifying antirheumatic drug) during the last 3 months prior to study entry
  • Change in treatment with SAARDs/DMARDs during the last 3 months prior to study entry or intended change during the trial duration
  • Change in treatment with corticosteroids during the last month prior to study entry or intended change during the trial duration with exception of local therapy for uveitis
  • One of the following therapies during the last 3 months prior to study entry or their intended use during the trial treatment period

    • Systemic treatment (except for intra-articular injections) with corticosteroids at a dose higher than 10 mg/day or 0.2 mg/kg/day (prednisone equivalent), respectively (whichever is lower)
    • Treatment with hydroxychloroquine at a dose higher than 10 mg/kg/day
    • Treatment with cyclosporine at a dose higher than 5 mg/kg/day
    • Treatment with methotrexate at a dose higher than 15 mg/m2/week
    • Treatment with other cytotoxic agents, gold compounds, D-penicillamine, Enbrel (etanercept), biologic agents and experimentals
  • Intra-articular injections of corticosteroids during the last month prior to study entry and intended injections during the first 4 weeks of the trial treatment period
  • Concomitant administration of other NSAIDs (including topical forms for skin with exception of local therapy for uveitis) or analgesic agents except paracetamol or acetaminophen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279747

Locations
Austria
Univ.-Klinik für Kinder- und Jugendheilkunde Wien
Wien, Austria, 1090
Gottfried Preyersches Kinderspital d. Stadt Wien
Wien, Austria, 1100 Wien
Landes-Kinderklinik Linz
Linz, Austria, 4020
Belgium
UZ Gent
Gent, Belgium, 9000
U.Z. Gasthuisberg
Leuven, Belgium, 3000
Boehringer Ingelheim Investigational Site
Merksem, Belgium, 2170
France
Boehringer Ingelheim Investigational Site
Paris, France
Boehringer Ingelheim Investigational Site
Vandoeuvre les Nancy, France
Boehringer Ingelheim Investigational Site
Marseille, France
Boehringer Ingelheim Investigational Site
Strasbourg, France
Boehringer Ingelheim Investigational Site
Lille, France
Boehringer Ingelheim Investigational Site
Angers, France
Germany
Boehringer Ingelheim Investigational Site
Hamburg, Germany, 22081
Martin-Luther-Universität Halle
Halle/Saale, Germany, 06097
Neurologie
Bremen, Germany, 28325
Bayrische Julius-Maximilians-Universität
Würzburg, Germany, 97080
Rheumaklinik Bad Bramstedt GmbH
Bad Bramstedt, Germany, 24572
Universität Erlangen
Erlangen, Germany, 91054
Italy
IRCCS Policlinico San Matteo
PAVIA, Italy, 27100
Ospedale Pediatrico Bambin Gesù
ROMA, Italy, 00165
Ospedale Meyer
FIRENZE, Italy, 50132
Istituto Ortopedico Gaetano Pini
MILANO, Italy, 20122
Istituto G. Gaslini
GENOVA, Italy, 16147
Clinica Pediatrica I
PADOVA, Italy, 35128
II Università degli Studi di Napoli
NAPOLI, Italy, 80129
IRCCS Burlo Garofalo
TRIESTE, Italy, 34137
Università Federico II
NAPOLI, Italy, 80131
Russian Federation
Institute of Rheumatology of RAMN
Moscow, Russian Federation, 115522
Medical Academy Setchenov
Moscow, Russian Federation, 119435
Scientific Research Institute of Pediatric Hematology
Moscow, Russian Federation, 117513
Medical Faculty of Russian People Friendship University
Moscow, Russian Federation, 117049
United Kingdom
Dept. of Child Health
London, United Kingdom, WC1N 3JH
Booth Hall Childrens Hospital
Manchester, United Kingdom, M9 7AA
Paediatric Department
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG
  More Information

Additional Information:
No publications provided

Study ID Numbers: 107.208
Study First Received: January 19, 2006
Last Updated: October 7, 2009
ClinicalTrials.gov Identifier: NCT00279747     History of Changes
Health Authority: Germany: Ministry of Health;   Austria: Ethikkommission;   Russia: Ethics Committee;   Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment;   France: Afssaps - French Health Products Safety Agency;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Arthritis, Rheumatoid
Gout Suppressants
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Naproxen
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Immune System Diseases
Joint Diseases
Meloxicam
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 04, 2010