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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00372801
First received: September 5, 2006
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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
Intervention Details:
    Drug: Ibuprofen
    Other Name: Ibuprofen
  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372801

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00372801     History of Changes
Other Study ID Numbers: COX103843
Study First Received: September 5, 2006
Last Updated: October 15, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Osteoarthritis
Ibuprofen
COX2
VAS
knee
single dose

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

ClinicalTrials.gov processed this record on April 16, 2014