Clinical Trial: 5% Topical Ibuprofen (IBU) for Ankle Sprain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain

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.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3) [ Time Frame: Over 3 Days (0-72 hours) ]
    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 ]
    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.


Original Primary Outcome:

  • Sum of pain intensity difference on weight bearing over 24 hours after first dose [ Time Frame: 24 hours ]
  • Sum of pain intensity difference on weight bearing over 3 days [ Time Frame: 3 days ]


Current Secondary Outcome:

  • Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24) [ Time Frame: 0 to 24 hours ]
    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 ]
    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 ]
    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 ]
    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 ]
    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) ]
    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) ]
    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 bas

    Original Secondary Outcome:

    • Sum of pain intensity difference at rest over 24 hours [ Time Frame: 24 hours ]
    • Subject Global Assessment of Ankle Injury [ Time Frame: Days 3 and 10 ]
    • Physician Global Assessment of Ankle Injury [ Time Frame: Days 3 and 10 ]
    • Ankle Pain at Rest [ Time Frame: Each post-dose time point through 7 days ]
    • Ankle Pain Upon Weight Bearing [ Time Frame: Each post-dose timepoing through 7 days ]
    • Time weighted sum of pain intensity difference at rest [ Time Frame: Over 6 hours on Day 1 and over 2 hours on Day 3 ]
    • Time weighted sum of pain intensity difference upon weight bearing [ Time Frame: Over 6 hours on Day 1 and over 2 hours on Day 3 ]
    • Time weighted pain intensity difference score [ Time Frame: Over each day, over 3 days, over 7 days ]
    • Subject assessment of normal function and activity [ Time Frame: Days 3 and 10 ]
    • Subject Global Assessment of Medication [ Time Frame: Day 10 ]
    • Time to onset of first perceptible relief [ Time Frame: First 6 hours after Dose 1 ]
    • Time to onset of meaningful relief [ Time Frame: First 6 hours after Dose 1 ]
    • Time to rescue medication after initial dose, and after each subsequent dose provided that at least 25% of subjects take rescue medication [ Time Frame: 10 days ]
    • Number of doses of rescue medication used [ Time Frame: First 7 days of dosing ]
    • Percentage of subjects taking rescue medication [ Time Frame: 10 days ]


    Information By: Pfizer

    Dates:
    Date Received: June 21, 2013
    Date Started: November 2013
    Date Completion:
    Last Updated: April 19, 2016
    Last Verified: April 2016