A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee

BioChemics, Inc.1 site in 1 country75 target enrollmentFebruary 2011

ConditionsOsteoarthritis

InterventionsIbuprofen placebo

DrugsIbuprofen placebo

Overview

Phase: Phase 2
Intervention: Ibuprofen
Conditions: Osteoarthritis
Sponsor: BioChemics, Inc.
Enrollment: 75
Locations: 1
Primary Endpoint: Visual Analogue Scale (VAS) Pain scale
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.

A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

August 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BioChemics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients aged at least 40 years.
•Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
•Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
•pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.

Exclusion Criteria

•Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
•Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
•Female patients who are pregnant or breast-feeding.