Prospective, Clinical Trial to Investigate Safety, Tolerability and Efficacy of Dexibuprofen Gebro 400 mg Powder for Oral Suspension (Test) Compared to Ibuprofen 400 mg Powder for Oral Suspension (Reference) in Patients Suffering From Osteoarthritis of the Hip or Knee
Overview
- Phase
- Phase 4
- Intervention
- Dexibuprofen
- Conditions
- Osteoarthritis of the Hip or Knee
- Sponsor
- Gebro Pharma GmbH
- Enrollment
- 482
- Locations
- 2
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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
Investigators
Eligibility 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
Arms & Interventions
Dexibuprofen
Dexibuprofen 400 mg powder for oral suspension
Intervention: Dexibuprofen
Ibuprofen
Ibuprofen 400 mg powder for oral suspension
Intervention: Ibuprofen
Outcomes
Primary Outcomes
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
Time Frame: 14 days
Secondary Outcomes
- 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(14 days)