- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01496326
Osteoarthritis Topical Treatment (ANTIPAIN)
December 19, 2011 updated by: BioChemics, Inc.
A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee
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 Overview
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Schaffhausen, Switzerland, 8200
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St. Gallen, Switzerland, 9000
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Zürich, Switzerland, 8001
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Zürich, Switzerland, 8050
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Zürich, Switzerland, 8091
- Rheumaklinik und Institut für Physikalische Medizin Universitätsspital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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2 grams of placebo cream for 14 days
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Experimental: Ibuprofen
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10% ibuprofen cream formulation at a dose of 200mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Analogue Scale (VAS) Pain scale
Time Frame: 14 days
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14 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stephen Carter, Ph.D., BioChemics, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
December 15, 2011
First Submitted That Met QC Criteria
December 19, 2011
First Posted (Estimate)
December 21, 2011
Study Record Updates
Last Update Posted (Estimate)
December 21, 2011
Last Update Submitted That Met QC Criteria
December 19, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- BC-IBU-CH-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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