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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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

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Conditions

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Osteoarthritis

Keywords

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Osteoarthritis Ibuprofen COX2 VAS knee single dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Randwick, Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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COX103843

Identifier Type: -

Identifier Source: org_study_id