Clinical trial NCT01794923: Topical Ibuprofen for Delayed Onset Mulscle Soreness
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Delayed onset muscle soreness
ibuprofen
topical
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )
timeFrame: Baseline, 0 to 24 hours post-Dose 1 on Day 1
Secondary outcomes:
measure: 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
timeFrame: Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1
measure: 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
timeFrame: Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
measure: 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
timeFrame: Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1
measure: 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
timeFrame: Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
measure: Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours
timeFrame: 0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1
measure: Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1
timeFrame: Baseline, 24 hours post-Dose 1
measure: Muscle Soreness Relief at Each Time Point
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
measure: Participant's Global Assessment of Medication at Day 4
timeFrame: Day 4
measure: Percentage of Participants Taking Rescue Medication
timeFrame: Baseline up to Day 4
measure: Time to First Use of Rescue Medication
timeFrame: Baseline up to Day 4
measure: Number of Doses of Rescue Medication
timeFrame: Baseline up to Day 4
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Institute for Applied Pharmaceutical Research
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: