Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2011-02-28
2011-08-31
Brief Summary
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A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ibuprofen
Ibuprofen
10% ibuprofen cream formulation at a dose of 200mg
Placebo
placebo
2 grams of placebo cream for 14 days
Interventions
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Ibuprofen
10% ibuprofen cream formulation at a dose of 200mg
placebo
2 grams of placebo cream for 14 days
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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BioChemics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Carter, Ph.D.
Role: STUDY_DIRECTOR
BioChemics, Inc.
Locations
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Sankt Gallen, , Switzerland
Schaffhausen, , Switzerland
Zurich, , Switzerland
Zurich, , Switzerland
Rheumaklinik und Institut für Physikalische Medizin Universitätsspital
Zurich, , Switzerland
Countries
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References
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Varadi G, Zhu Z, Blattler T, Hosle M, Loher A, Pokorny R, Frey D, Carter SG. Randomized clinical trial evaluating transdermal Ibuprofen for moderate to severe knee osteoarthritis. Pain Physician. 2013 Nov-Dec;16(6):E749-62.
Other Identifiers
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BC-IBU-CH-001
Identifier Type: -
Identifier Source: org_study_id