Trial | NCT01066676  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    482
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
Study Started
Oct 31
2009
Primary Completion
Jun 30
2012
Study Completion
Jun 30
2012
Last Update
Jul 10
2012
Estimate

Drug Dexibuprofen

400mg powder for oral suspension, daily dose 800mg

Drug Ibuprofen

400mg, powder for oral suspension, daily dose 1600mg

Dexibuprofen Experimental

Dexibuprofen 400 mg powder for oral suspension

Ibuprofen Active Comparator

Ibuprofen 400 mg powder for oral suspension

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
No Results Posted