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

NCT ID: NCT01066676

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

482 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Osteoarthritis of the Hip or Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dexibuprofen

Dexibuprofen 400 mg powder for oral suspension

Group Type EXPERIMENTAL

Dexibuprofen

Intervention Type DRUG

400mg powder for oral suspension, daily dose 800mg

Ibuprofen

Ibuprofen 400 mg powder for oral suspension

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

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

Interventions

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Dexibuprofen

400mg powder for oral suspension, daily dose 800mg

Intervention Type DRUG

Ibuprofen

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gebro Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reinhold Hawel, MD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitationszentrum, Bad Hofgastein

Locations

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Rehabzentrum für Erkrankungen des rheumat. Formenkreises

Bad Hofgastein, Salzburg, Austria

Site Status

Rheuma Zentrum Favoriten

Vienna, , Austria

Site Status

Countries

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Austria

Related Links

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http://www.gebro.com

Related Info

Other Identifiers

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IV/48.4

Identifier Type: -

Identifier Source: org_study_id