A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA) | Completed
A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)
Health Conditions
  • Arthritis, Juvenile Rheumatoid
Completed
Recruitment Status
NCT00279747
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • Response rates according to ACR Ped 30; after 12 weeks of treatment
Secondary Outcome Measures
  • Global assessment of overall disease activity by investigator; up to 12 months; Parent global assessment of overall well-being; up to 12 months; Assessment of functional disability by means of Childhood Health Assessment Questionnaire (CHAQ); up to 12 months; Number of joints with active arthritis; up to 12 months; Number of joints with limited range of motion; up to 12 months; Erythrocyte Sedimentation Rate (ESR); up to 12 months; Parent global assessment of arthritis; up to 12 months; Parent global assessment of pain; up to 12 months; Children's assessment of discomfort; up to 12 months; Change in functional classification (Steinbrocker classification); up to 12 months; Final global assessment of efficacy by parent; week 12, 12 months; Final global assessment of efficacy by investigator; week 12, 12 months; Withdrawals due to inadequate efficacy; up to 12 months; Paracetamol / acetaminophen consumption; up to 12 months; Final global assessment of tolerability by parent; week 12, 12 months; Final global assessment of tolerability by investigator; week 12, 12 months; Incidence and intensity of adverse events (AEs); 12 months; Incidence of laboratory adverse events; 12 months; Withdrawal due to adverse event; 12 months; Duration of hospital stay due to gastrointestinal serious adverse event (GI-SAE); week 12, 12 months; Duration of hospital stay due to adverse events related to trial drug administration; week 12, 12 months; Additional visits to a physician due to gastrointestinal adverse event (GI-AE); week 12, 12 months
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
Austria; Belgium; France; Germany; Italy; Russian Federation; United Kingdom
Participant Sex
Both
Participant Age Range
2 Years to 16 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion 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
Interventions
Drug; meloxicam 0.25 mg/kg; null; []; Drug; meloxicam 0.125 mg/kg; null; []; Drug; naproxen 10 mg/kg; null; []
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific 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.
Secondary Trial Identifying Number
Sorry, this information is not available
Website
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.208_U03-1727.pdf; http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.208_literature.pdf
Study Funded By
Boehringer Ingelheim
Funder Type
Sorry, this information is not available
Study Sponsored By
Boehringer Ingelheim
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

19 Jan 2006

Last Updated

31 Oct 2013

Date Record Refreshed on UKCTG

25 Jul 2015