NCT01066676

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: Gebro Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis of the Hip or Knee

Interventions

Type	Name	Description
DRUG	Dexibuprofen	400mg powder for oral suspension, daily dose 800mg
DRUG	Ibuprofen	400mg, powder for oral suspension, daily dose 1600mg

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-02-10
• Last updated: 2012-07-10

Locations

2 sites across 1 country: Austria