Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Medical condition under investigation: Osteoarthritis of the hip or knee

Number of patients planned: 480 adult patients

Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee

Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gebro Pharma GmbH
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• male or female patients aged between 18 and 75 years

• everyday joint pain for the past three months

• global pain intensity in the involved joint (hip or knee) of "moderate" to "severe" within the last 48 h

Exclusion Criteria:

• acute inflammation or ischaemic necrosis

• paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint

• slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology

• hip/knee arthropathy due to diabetes mellitus

• Charcot's joint

• villous synovitis

• chondromatosis of the synovium

• patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months