Osteoarthritis Topical Treatment
- Registration Number
- NCT01496326
- Lead Sponsor
- BioChemics, Inc.
- 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.)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Ibuprofen Ibuprofen -
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) Pain scale 14 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rheumaklinik und Institut für Physikalische Medizin Universitätsspital
🇨🇭Zürich, Switzerland