Phase 3
N=205
Topical Ibuprofen for Delayed Onset Mulscle Soreness
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01794923 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 ) — 22.2; 17.8; 29.7 units on a scale — p=0.200
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IBU BID (Drug); Placebo BID (Drug); IBU TID (Drug); Placebo TID (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 ) |
22.2; 17.8; 29.7 | 0.200 |
| SECONDARY Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1 |
78.3; 81.0; 85.4; 149.6; 150.5; 135.6 | 0.860 |
| SECONDARY Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1 |
-0.0; -0.1; -0.2; 0.1; -0.2; -0.0 | 0.630 |
| SECONDARY Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1 |
21.8; 18.7; 24.6; 77.3; 78.0; 73.1 | 0.702 |
| SECONDARY Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1 |
0.0; 0.1; -0.1; 0.1; -0.0; -0.2 | 0.219 |
| SECONDARY Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours |
18.8; 16.8; 23.4; 57.3; 56.4; 58.4 | 0.163 |
| SECONDARY Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1 |
1.6; 1.7; 2.1 | 0.533 |
| SECONDARY Muscle Soreness Relief at Each Time Point |
0.1; 0.1; 0.0; 0.2; 0.2; 0.2 | 0.189 |
| SECONDARY Participant's Global Assessment of Medication at Day 4 |
2.3; 2.4; 2.2 | 0.751 |
| SECONDARY Percentage of Participants Taking Rescue Medication |
0; 0; 0 | — |
| SECONDARY Time to First Use of Rescue Medication |
— | — |
| SECONDARY Number of Doses of Rescue Medication |
— | — |
Summary
The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel versus placebo administered two or three times daily for the treatment of pain associated with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor muscles.
Eligibility Criteria
Inclusion Criteria
Males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness activities for a minimum of 3 months prior to entry in the study; subjects must be willing to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice, massage) and other forms of soreness relief during the study
Exclusion Criteria
Use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs
Data sourced from ClinicalTrials.gov (NCT01794923). 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.