Phase II Study of AP0302 5% Versus a Vehicle Comparator
NCT ID: NCT02324985
Last Updated: 2019-02-25
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
147 participants
INTERVENTIONAL
2015-01-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Arm
S-Ibuprofen Topical Gel 5%
S-Ibuprofen Topical Gel 5%
S-Ibuprofen Topical Gel 5% applied every 6 hours
Placebo Arm
Vehicle Topical Gel
Vehicle Topical Gel
Vehicle Topical Gel applied every 6 hours
Interventions
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S-Ibuprofen Topical Gel 5%
S-Ibuprofen Topical Gel 5% applied every 6 hours
Vehicle Topical Gel
Vehicle Topical Gel applied every 6 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI between 18-30
* negative drug, alcohol, pregnancy screens
Exclusion Criteria
* no job requiring heavy lifting
* history of muscle disorders
* allergy or intolerance to study drug
* history of recent pain medication use
18 Years
35 Years
ALL
Yes
Sponsors
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Aponia Laboratories, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sonia Singla, DO
Role: PRINCIPAL_INVESTIGATOR
Lotus Clinical Research
Locations
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Lotus Clinical Research, LLC
Pasadena, California, United States
Countries
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Other Identifiers
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AP-005
Identifier Type: -
Identifier Source: org_study_id
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