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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
226
Response rates according to ACR Ped 30
Time frame: after 12 weeks of treatment
Global assessment of overall disease activity by investigator
Time frame: up to 12 months
Parent global assessment of overall well-being
Time frame: up to 12 months
Assessment of functional disability by means of Childhood Health Assessment Questionnaire (CHAQ)
Time frame: up to 12 months
Number of joints with active arthritis
Time frame: up to 12 months
Number of joints with limited range of motion
Time frame: up to 12 months
Erythrocyte Sedimentation Rate (ESR)
Time frame: up to 12 months
Parent global assessment of arthritis
Time frame: up to 12 months
Parent global assessment of pain
Time frame: up to 12 months
Children's assessment of discomfort
Time frame: up to 12 months
Change in functional classification (Steinbrocker classification)
Time frame: up to 12 months
Final global assessment of efficacy by parent
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Landes-Kinderklinik Linz
Linz, Austria
Univ.-Klinik für Kinder- und Jugendheilkunde Wien
Vienna, Austria
Gottfried Preyersches Kinderspital d. Stadt Wien
Vienna, Austria
UZ Gent
Ghent, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Boehringer Ingelheim Investigational Site
Merksem, Belgium
Boehringer Ingelheim Investigational Site
Angers, France
Boehringer Ingelheim Investigational Site
Lille, France
Boehringer Ingelheim Investigational Site
Marseille, France
Boehringer Ingelheim Investigational Site
Paris, France
...and 24 more locations
Time frame: week 12, 12 months
Final global assessment of efficacy by investigator
Time frame: week 12, 12 months
Withdrawals due to inadequate efficacy
Time frame: up to 12 months
Paracetamol / acetaminophen consumption
Time frame: up to 12 months
Final global assessment of tolerability by parent
Time frame: week 12, 12 months
Final global assessment of tolerability by investigator
Time frame: week 12, 12 months
Incidence and intensity of adverse events (AEs)
Time frame: 12 months
Incidence of laboratory adverse events
Time frame: 12 months
Withdrawal due to adverse event
Time frame: 12 months
Duration of hospital stay due to gastrointestinal serious adverse event (GI-SAE)
Time frame: week 12, 12 months
Duration of hospital stay due to adverse events related to trial drug administration
Time frame: week 12, 12 months
Additional visits to a physician due to gastrointestinal adverse event (GI-AE)
Time frame: week 12, 12 months