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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gebro Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01066676
First received: February 9, 2010
Last updated: July 9, 2012
Last verified: July 2012

February 9, 2010
July 9, 2012
October 2009
June 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01066676 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Hip or Knee
  • Drug: Dexibuprofen
    400mg powder for oral suspension, daily dose 800mg
  • Drug: Ibuprofen
    400mg, powder for oral suspension, daily dose 1600mg
  • Experimental: Dexibuprofen
    Dexibuprofen 400 mg powder for oral suspension
    Intervention: Drug: Dexibuprofen
  • Active Comparator: Ibuprofen
    Ibuprofen 400 mg powder for oral suspension
    Intervention: Drug: Ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
482
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01066676
IV/48.4
No
Gebro Pharma GmbH
Gebro Pharma GmbH
Not Provided
Principal Investigator: Reinhold Hawel, MD Rehabilitationszentrum, Bad Hofgastein
Gebro Pharma GmbH
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP