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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

Page last updated: August 23, 2015

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