Back to resultsEffectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Ibuprofen, COX2, VAS, knee, single dose
Eligibility Criteria
Inclusion criteria:
- Subjects diagnosed with primary Osteoarthritis of the knee.
- Have at least 3 months in symptom duration prior to screening visit.
- Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
- Pain walking on flat surface within specific interval prior to study start.
Exclusion criteria:
- History of hypersensitivity to NSAIDS.
- Allergy to Ibuprofen.
- Use of assistive devices other than a cane or knee brace.
- History of specified diseases/illnesses.
- Abnormal blood tests pre-study.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).
Secondary Outcome Measures
Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372801
Brief Title
Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee
Official Title
A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Pilot Study to Investigate the Efficacy of Ibuprofen in Patients With Osteoarthritis of the Knee Following Administration of a Single Dose
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Ibuprofen, COX2, VAS, knee, single dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Primary Outcome Measure Information:
Title
Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).
Secondary Outcome Measure Information:
Title
Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Subjects diagnosed with primary Osteoarthritis of the knee.
Have at least 3 months in symptom duration prior to screening visit.
Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
Pain walking on flat surface within specific interval prior to study start.
Exclusion criteria:
History of hypersensitivity to NSAIDS.
Allergy to Ibuprofen.
Use of assistive devices other than a cane or knee brace.
History of specified diseases/illnesses.
Abnormal blood tests pre-study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Randwick, Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
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Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee
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