5% Topical Ibuprofen (IBU) for Ankle Sprain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01945034
First received: June 21, 2013
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Ankle Injuries
Drug: Topical IBU twice daily
Drug: Placebo twice daily
Drug: Topical IBU three times daily
Drug: Placebo three times daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3) [ Time Frame: Over 3 Days (0-72 hours) ] [ Designated as safety issue: No ]
    PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.

  • Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24) [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]
    PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.


Secondary Outcome Measures:
  • Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24) [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]
    PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

  • Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10 [ Time Frame: Baseline, Day 3, 10 ] [ Designated as safety issue: No ]
    Participant's global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).

  • Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10 [ Time Frame: Baseline, Day 3, 10 ] [ Designated as safety issue: No ]
    The physician assessment of the severity of the ankle injury was based on the participant's individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.

  • Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points [ Time Frame: 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 ] [ Designated as safety issue: No ]
    PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.

  • Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3 [ Time Frame: Over 6 hours on Day 1, over 2 hours on Day 3 ] [ Designated as safety issue: No ]
    PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

  • Sum of Pain Intensity Difference Scores at Rest Over 3 Days [ Time Frame: Over 3 Days (0-72 hours) ] [ Designated as safety issue: No ]
    PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

  • Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days [ Time Frame: Over 7 days (0-168 hours) ] [ Designated as safety issue: No ]
    PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

  • Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10 [ Time Frame: Baseline, Day 3, 10 ] [ Designated as safety issue: No ]
    Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can't resume normal activities; 4= Moderately restricted walking due to pain and can't resume normal activities; 5= Severely restricted walking due to pain and can't resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity.

  • Participant's Global Assessment of Medication at End of Study [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.

  • Time to First Perceptible Relief and Meaningful Relief [ Time Frame: 0 to 3 hours on Day 1 ] [ Designated as safety issue: No ]
    Participants evaluated time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at moment participant first began to experience any relief, exact question asked was: "Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief". First perceptible relief was considered confirmed by meaningful relief if participant achieved both "first perceptible" and "meaningful" relief by either pressing second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful". For "time to meaningful relief," exact question asked was: "Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you." Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered.

  • Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose [ Time Frame: Post-Dose on Day 1 up to Day 10 ] [ Designated as safety issue: No ]
    Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.

  • Number of Doses of Rescue Medication Used During the First 7 Days of Dosing [ Time Frame: Baseline up to Day 7 ] [ Designated as safety issue: No ]
    Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.

  • Percentage of Participants Taking Rescue Medication [ Time Frame: Post first dose Day 1 up to Day 10 ] [ Designated as safety issue: No ]
    Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.


Enrollment: 304
Study Start Date: November 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical IBU twice daily Drug: Topical IBU twice daily
Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
Placebo Comparator: Placebo twice daily Drug: Placebo twice daily
Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
Experimental: Topical IBU three times daily Drug: Topical IBU three times daily
Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
Placebo Comparator: Placebo three times daily Drug: Placebo three times daily
Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945034

Locations
United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
United States, California
Orange County Research Institute
Anaheim, California, United States, 92801
eStudy Site
San Diego, California, United States, 92120
San Diego Sports Medicine and Family Health Center
San Diego, California, United States, 92120
United States, Florida
L&L Research Choices
Miami, Florida, United States, 33144
Sunrise Research Institute, Inc.
Miami, Florida, United States, 33130
Doctors Research Network
S. Miami, Florida, United States, 33143
United States, Idaho
Elite Clinical Trials LLLP
Blackfoot, Idaho, United States, 83221
United States, Louisiana
MedPharmics, LLC
Metairie, Louisiana, United States, 70006
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States, 68134
United States, North Carolina
PMG Research of Salisbury
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Lillestol Research, LLC
Fargo, North Dakota, United States, 58103
United States, Texas
Clinical Trial Network
Houston, Texas, United States, 77074
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sports Medicine Associates of San Antonio
San Antonio, Texas, United States, 78240
United States, Virginia
Danville Orthopedic Clinic
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01945034     History of Changes
Other Study ID Numbers: B3491009 
Study First Received: June 21, 2013
Results First Received: August 19, 2015
Last Updated: April 19, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
topical ibuprofen
ankle sprain

Additional relevant MeSH terms:
Ankle Injuries
Sprains and Strains
Leg Injuries
Wounds and Injuries
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016