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Phase 3 Completed N=205 Randomized Quadruple-blind Treatment

Topical Ibuprofen for Delayed Onset Mulscle Soreness

Source: ClinicalTrials.gov NCT01794923 ↗
Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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