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| 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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. |
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2000 |
| Estimated Study Completion Date: | January 2003 |
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 |
Inclusion Criteria:
Diagnosis of idiopathic arthritis of childhood by ILAR criteria:
Patients requiring therapy with NSAIDs, i.e., the patient fits into one of the following categories:
Exclusion Criteria:
One of the following therapies during the last 3 months prior to study entry or their intended use during the trial treatment period
Contacts and Locations| Austria | |
| Landes-Kinderklinik Linz | |
| Linz, Austria, 4020 | |
| Univ.-Klinik für Kinder- und Jugendheilkunde Wien | |
| Wien, Austria, 1090 | |
| Gottfried Preyersches Kinderspital d. Stadt Wien | |
| Wien, Austria, 1100 Wien | |
| Belgium | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Boehringer Ingelheim Investigational Site | |
| Merksem, Belgium, 2170 | |
| France | |
| Boehringer Ingelheim Investigational Site | |
| Angers, France | |
| Boehringer Ingelheim Investigational Site | |
| Lille, France | |
| Boehringer Ingelheim Investigational Site | |
| Marseille, France | |
| Boehringer Ingelheim Investigational Site | |
| Paris, France | |
| Boehringer Ingelheim Investigational Site | |
| Strasbourg, France | |
| Boehringer Ingelheim Investigational Site | |
| Vandoeuvre les Nancy, France | |
| Germany | |
| Rheumaklinik Bad Bramstedt GmbH | |
| Bad Bramstedt, Germany, 24572 | |
| Neurologie | |
| Bremen, Germany, 28325 | |
| Universität Erlangen | |
| Erlangen, Germany, 91054 | |
| Martin-Luther-Universität Halle | |
| Halle/Saale, Germany, 06097 | |
| Boehringer Ingelheim Investigational Site | |
| Hamburg, Germany, 22081 | |
| Bayrische Julius-Maximilians-Universität | |
| Würzburg, Germany, 97080 | |
| Italy | |
| Ospedale Meyer | |
| Firenze, Italy, 50132 | |
| Istituto G. Gaslini | |
| Genova, Italy, 16147 | |
| Istituto Ortopedico Gaetano Pini | |
| Milano, Italy, 20122 | |
| II Università degli Studi di Napoli | |
| Napoli, Italy, 80129 | |
| Università Federico II | |
| Napoli, Italy, 80131 | |
| Clinica Pediatrica I | |
| Padova, Italy, 35128 | |
| IRCCS Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Ospedale Pediatrico Bambin Gesù | |
| Roma, Italy, 00165 | |
| IRCCS Burlo Garofalo | |
| Trieste, Italy, 34137 | |
| 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 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
More Information
| ClinicalTrials.gov Identifier: | NCT00279747 History of Changes |
| Other Study ID Numbers: | 107.208 |
| Study First Received: | January 19, 2006 |
| Last Updated: | October 7, 2009 |
| 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 |
|
Arthritis Arthritis, Rheumatoid Arthritis, Juvenile Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Naproxen Meloxicam Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |