Pain, Delayed Onset Muscle Soreness
Conditions
Keywords
muscle soreness
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.
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).
Interventions
DRUGS-Ibuprofen Topical Gel 5%
S-Ibuprofen Topical Gel 5% applied every 6 hours
Vehicle Topical Gel applied every 6 hours
Sponsors
Aponia Laboratories, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement | 0-24 hours | SPID 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement | 0-48 hours | SPID 48movement |
| Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest | 0-48 hours | SPID 48rest |
Countries
United States
Outcome results
None listed