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

Phase 4

Completed

• Conditions: Osteoarthritis of the Hip or Knee
• Interventions: Drug: Dexibuprofen; Drug: Ibuprofen

• Registration Number: NCT01066676
• Lead Sponsor: Gebro Pharma GmbH

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 482

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexibuprofen	Dexibuprofen	Dexibuprofen 400 mg powder for oral suspension
Ibuprofen	Ibuprofen	Ibuprofen 400 mg powder for oral suspension

Primary Outcome Measures

Name	Time	Method
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	14 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Rheuma Zentrum Favoriten; 🇦🇹 Vienna, Austria

Rehabzentrum für Erkrankungen des rheumat. Formenkreises; 🇦🇹 Bad Hofgastein, Salzburg, Austria