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

This study has been completed.

First Received: September 5, 2006 Last Updated: October 15, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00372801

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ibuprofen

U.S. FDA Resources

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

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:	GSK ( Study Director )
Study ID Numbers:	COX103843
Study First Received:	September 5, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00372801 History of Changes
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:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Osteoarthritis, Knee

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010