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

Primary Purpose

Osteoarthritis of the Hip or Knee

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Dexibuprofen
Ibuprofen
Sponsored by
Gebro Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Hip or Knee

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabzentrum für Erkrankungen des rheumat. Formenkreises
  • Rheuma Zentrum Favoriten

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexibuprofen

Ibuprofen

Arm Description

Dexibuprofen 400 mg powder for oral suspension

Ibuprofen 400 mg powder for oral suspension

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
February 9, 2010
Last Updated
July 9, 2012
Sponsor
Gebro Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01066676
Brief Title
Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gebro Pharma GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Hip or Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
482 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexibuprofen
Arm Type
Experimental
Arm Description
Dexibuprofen 400 mg powder for oral suspension
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 400 mg powder for oral suspension
Intervention Type
Drug
Intervention Name(s)
Dexibuprofen
Intervention Description
400mg powder for oral suspension, daily dose 800mg
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
400mg, powder for oral suspension, daily dose 1600mg
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhold Hawel, MD
Organizational Affiliation
Rehabilitationszentrum, Bad Hofgastein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabzentrum für Erkrankungen des rheumat. Formenkreises
City
Bad Hofgastein
State/Province
Salzburg
ZIP/Postal Code
5630
Country
Austria
Facility Name
Rheuma Zentrum Favoriten
City
Vienna
ZIP/Postal Code
1100
Country
Austria

12. IPD Sharing Statement

Links:
URL
http://www.gebro.com
Description
Related Info

Learn more about this trial

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

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