Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee
Information source: Gebro Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis of the Hip or Knee
Intervention: Dexibuprofen (Drug); Ibuprofen (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Gebro Pharma GmbH Official(s) and/or principal investigator(s): Reinhold Hawel, MD, Principal Investigator, Affiliation: Rehabilitationszentrum, Bad Hofgastein
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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 outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Rheuma Zentrum Favoriten, Vienna 1100, Austria
Rehabzentrum für Erkrankungen des rheumat. Formenkreises, Bad Hofgastein, Salzburg 5630, Austria
Additional Information
Starting date: October 2009
Last updated: July 9, 2012
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