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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 7, 2006
Last Update Posted: October 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
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.

Condition Intervention Phase
Osteoarthritis Drug: Ibuprofen Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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)

Estimated Enrollment: 36
Study Start Date: August 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372801

Australia, New South Wales
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00372801     History of Changes
Other Study ID Numbers: COX103843
First Submitted: September 5, 2006
First Posted: September 7, 2006
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
single dose

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action