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

NCT01066676 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2012-07-10

No results posted yet for this study

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

Conditions

  • Osteoarthritis of the Hip or Knee

Interventions

DRUG

Dexibuprofen

400mg powder for oral suspension, daily dose 800mg

DRUG

Ibuprofen

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

Sponsors & Collaborators

  • Gebro Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Reinhold Hawel, MD · Rehabilitationszentrum, Bad Hofgastein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Austria

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01066676 on ClinicalTrials.gov