Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372801
• Other study ID #: COX103843
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2006
• Last updated: October 15, 2008
• Start date: August 2005

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Ibuprofen

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Randwick, Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)