Status:
COMPLETED
Osteoarthritis Topical Treatment
Lead Sponsor:
BioChemics, Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01496326
Start Date
February 1 2011
End Date
August 1 2011
Last Update
December 21 2011
Active Locations (5)
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1
Sankt Gallen, Switzerland, 9000
2
Schaffhausen, Switzerland, 8200
3
Zurich, Switzerland, 8001
4
Zurich, Switzerland, 8050