Clinical Trial: A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Adm

Brief 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.

Detailed Summary:

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.


Sponsor: Boehringer Ingelheim

Current Primary Outcome: Response rates according to ACR Ped 30 [ Time Frame: after 12 weeks of treatment ]

Original Primary Outcome: Response rates according to ACR Ped 30

Current Secondary Outcome:

  • 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 [ 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 ]


Original Secondary Outcome: 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

Information By: Boehringer Ingelheim

Dates:
Date Received: January 19, 2006
Date Started: September 2000
Date Completion:
Last Updated: October 31, 2013
Last Verified: October 2013