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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 5, 2006

Last Updated Date

October 15, 2008

Start Date ^ICMJE

August 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00372801 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)

Original Secondary Outcome Measures ^ICMJE

Responder rate
Patient impression of change - 8 & 24 hrs post dose
Time to use of rescue medication (paracetamol)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Drug: Ibuprofen

Other Name: Ibuprofen

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00372801

Other Study ID Numbers ^ICMJE

COX103843

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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