Osteoarthritis
Conditions
Keywords
Osteoarthritis, knee pain
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.)
Interventions
DRUGIbuprofen
10% ibuprofen cream formulation at a dose of 200mg
DRUGplacebo
2 grams of placebo cream for 14 days
Sponsors
BioChemics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) Pain scale | 14 days |
Countries
Switzerland
Outcome results
None listed