PLACEBO-CONTROLLED, DOUBLE-BLIND EVALUATION OF THE EFFICACY AND SAFETY OF IBUPROFEN 5% TOPICAL GEL FOR THE TREATMENT OF DELAYED-ONSET MUSCLE SORENESS OF THE ELBOW FLEXOR MUSCLES

IBU BID

Placebo BID

IBU TID

Placebo TID

Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )

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

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

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

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

Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours

Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1

Muscle Soreness Relief at Each Time Point

Participant's Global Assessment of Medication at Day 4

Percentage of Participants Taking Rescue Medication

Time to First Use of Rescue Medication

Number of Doses of Rescue Medication