Phase 2
N=251
Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS
Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT03852459 ↗Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero — -33.09; -29.09 score on a scale*hours — p=0.4272
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- S-Ibuprofen (Drug); Vehicle (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aponia Laboratories, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero |
-33.09; -29.09 | 0.4272 |
| SECONDARY SPIDMOVE Over the Following Intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48 and 0-48 Hours Post-T0. |
-4.82; -4.06; -8.98; -7.73; -13.80; -11.79 | — |
| SECONDARY Sum of Time Weighted Differences From Baseline in Muscle Stiffness (SSID) With Movement Over the Interval |
-3.81; -3.33; -7.75; -6.48; -11.55; -9.81 | — |
| SECONDARY Total Relief With Movement (TOTPAR) 0-6 Hours Post Time Zero |
4.06; 3.61 | — |
| SECONDARY Subject Global Assessment of Study Medication Assessed at Approximately 48 Hours Post Time Zero |
44; 50; 48; 47; 25; 21 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
125; 121; 124; 120; 2; 2 | — |
Summary
Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%
Eligibility Criteria
Inclusion Criteria
- history of pain/soreness after exercise
- BMI between 18-30
- negative drug, alcohol, pregnancy screens
- other protocol-defined inclusion criteria may apply
Exclusion Criteria
- upper extremity workout in last 3 months
- job or hobby requiring heavy lifting
- history of muscle disorders
- allergy or intolerance to NSAID or study drug
- history of recent pain medication use
- other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03852459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.