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
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Hip or Knee
Drug: Dexibuprofen
Drug: Ibuprofen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gebro Pharma GmbH:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 482
Study Start Date: October 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexibuprofen
Dexibuprofen 400 mg powder for oral suspension
Drug: Dexibuprofen
400mg powder for oral suspension, daily dose 800mg
Active Comparator: Ibuprofen
Ibuprofen 400 mg powder for oral suspension
Drug: Ibuprofen
400mg, powder for oral suspension, daily dose 1600mg

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066676

Locations
Austria
Rehabzentrum für Erkrankungen des rheumat. Formenkreises
Bad Hofgastein, Salzburg, Austria, 5630
Rheuma Zentrum Favoriten
Vienna, Austria, 1100
Sponsors and Collaborators
Gebro Pharma GmbH
Investigators
Principal Investigator: Reinhold Hawel, MD Rehabilitationszentrum, Bad Hofgastein
  More Information

Additional Information:
No publications provided

Responsible Party: Gebro Pharma GmbH
ClinicalTrials.gov Identifier: NCT01066676     History of Changes
Other Study ID Numbers: IV/48.4
Study First Received: February 9, 2010
Last Updated: July 9, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014