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Phase II Study of AP0302 5% Versus a Vehicle Comparator

Sponsor
Aponia Laboratories, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02324985
Collaborator
(none)
147
Enrollment
1
Location
2
Arms
17
Actual Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

Condition or Disease Intervention/Treatment Phase
  • Drug: S-Ibuprofen Topical Gel 5%
  • Drug: Vehicle Topical Gel
 Phase 2

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

Study Design

Study Type:
Interventional
Actual Enrollment :
147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active Arm

S-Ibuprofen Topical Gel 5%

Drug: S-Ibuprofen Topical Gel 5%
S-Ibuprofen Topical Gel 5% applied every 6 hours
Other Names:
  • Active Gel

    		•
    Placebo Comparator: Placebo Arm

    Vehicle Topical Gel

    Drug: Vehicle Topical Gel
    Vehicle Topical Gel applied every 6 hours
    Other Names:
  • Vehicle Gel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement [0-24 hours]

      SPID 24

    Secondary Outcome Measures

    1. Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement [0-48 hours]

      SPID 48movement

    2. Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest [0-48 hours]

      SPID 48rest

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • no clinically significant medical conditions

    • BMI between 18-30

    • negative drug, alcohol, pregnancy screens

    • other protocol-defined inclusion criteria may apply

    Exclusion Criteria:

    • no upper extremity workout in last 6 months

    • no job requiring heavy lifting

    • history of muscle disorders

    • allergy or intolerance to study drug

    • history of recent pain medication use

    • other protocol-defined exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lotus Clinical Research, LLC Pasadena California United States 91105

    Sponsors and Collaborators

    • Aponia Laboratories, Inc.

    Investigators

    • Principal Investigator: Sonia Singla, DO, Lotus Clinical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aponia Laboratories, Inc.
    ClinicalTrials.gov Identifier:
    NCT02324985
    Other Study ID Numbers:
    • AP-005
    First Posted:
    Dec 24, 2014
    Last Update Posted:
    Feb 25, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Aponia Laboratories, Inc.
    muscle soreness
    Additional relevant MeSH terms:
    Myalgia
    Ibuprofen

    Study Results

    No Results Posted as of Feb 25, 2019