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

Osteoarthritis of the Hip or Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066676
• Other study ID #: IV/48.4
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2010
• Last updated: July 9, 2012
• Start date: October 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Gebro Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Hip or Knee
• Osteoarthritis, Hip

Intervention

Drug:
• Dexibuprofen
400mg powder for oral suspension, daily dose 800mg
• Ibuprofen
400mg, powder for oral suspension, daily dose 1600mg

Locations

Country	Name	City	State
Austria	Rehabzentrum für Erkrankungen des rheumat. Formenkreises	Bad Hofgastein	Salzburg
Austria	Rheuma Zentrum Favoriten	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Gebro Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		14 days	Yes
Secondary	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		14 days	Yes

External Links

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