Clinical trial NCT01945034: 5% Topical Ibuprofen (IBU) for Ankle Sprain
Official title: Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankle Injuries
Keywords: topical ibuprofen
ankle sprain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-18
Enrollment: 304
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.


Eligibility criteria: Inclusion Criteria:

* First or second degree ankle sprain within 48 hours of first dose of study medication
* Medically cleared to participate

Exclusion Criteria:

* Similar injury of same joint within last 6 months
* Requires bed rest, surgery, or over-the-counter or prescription analgesics

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)
timeFrame: Over 3 Days (0-72 hours)
measure: Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)
timeFrame: 0 to 24 hours
Secondary outcomes:
measure: Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)
timeFrame: 0 to 24 hours
measure: Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10
timeFrame: Baseline, Day 3, 10
measure: Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10
timeFrame: Baseline, Day 3, 10
measure: Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1
measure: Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3
timeFrame: Over 6 hours on Day 1, over 2 hours on Day 3
measure: Sum of Pain Intensity Difference Scores at Rest Over 3 Days
timeFrame: Over 3 Days (0-72 hours)
measure: Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days
timeFrame: Over 7 days (0-168 hours)
measure: Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10
timeFrame: Baseline, Day 3, 10
measure: Participant's Global Assessment of Medication at End of Study
timeFrame: Day 10
measure: Time to First Perceptible Relief and Meaningful Relief
timeFrame: 0 to 3 hours on Day 1
measure: Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose
timeFrame: Post-Dose on Day 1 up to Day 10
measure: Number of Doses of Rescue Medication Used During the First 7 Days of Dosing
timeFrame: Baseline up to Day 7
measure: Percentage of Participants Taking Rescue Medication
timeFrame: Post first dose Day 1 up to Day 10
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Helen Keller Hospital
state: Alabama
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: San Diego
country: United States
facility: eStudy Site
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine and Family Health Center
state: California
city: Miami
country: United States
facility: Sunrise Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: L&L Research Choices
state: Florida
city: S. Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Blackfoot
country: United States
facility: Elite Clinical Trials LLLP
state: Idaho
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: San Antonio
country: United States
facility: Sports Medicine Associates of San Antonio
state: Texas
city: Danville
country: United States
facility: Danville Orthopedic Clinic
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: