Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With 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

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Key information

Conditions

Osteoarthritis of the Hip or Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rehabzentrum für Erkrankungen des rheumat. Formenkreises, Bad Hofgastein, State of Salzburg, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexibuprofen

Drug

400mg powder for oral suspension, daily dose 800mg

Ibuprofen

Drug

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

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Gebro Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Feb 10, 2010
Registry last updated: Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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