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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: September 5, 2006
Last updated: October 15, 2008
Last verified: October 2008
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-Blind
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

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.
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Please refer to this study by its identifier: 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 Identifier: NCT00372801     History of Changes
Other Study ID Numbers: COX103843
Study First Received: September 5, 2006
Last Updated: October 15, 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 processed this record on July 19, 2017