Osteoarthritis Topical Treatment

BioChemics, Inc.75 enrolled

Overview

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.)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis

Interventions

IbuprofenDRUG

10% ibuprofen cream formulation at a dose of 200mg

placeboDRUG

2 grams of placebo cream for 14 days

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (5)

Unnamed facility

Sankt Gallen, Switzerland

Unnamed facility

Schaffhausen, Switzerland

Unnamed facility

Zurich, Switzerland

Unnamed facility

Zurich, Switzerland

Rheumaklinik und Institut für Physikalische Medizin Universitätsspital

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS) Pain scale

Time frame: 14 days

Data from ClinicalTrials.gov

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