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

GlaxoSmithKline36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis

Interventions

IbuprofenDRUG

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Randwick, Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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