Osteoarthritis Topical Treatment (ANTIPAIN)

BioChemics

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis

Treatments

Drug: Ibuprofen

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01496326

BC-IBU-CH-001

Details and patient eligibility

About

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.)

Enrollment

75 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main 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.

Main 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.