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Trial record 1 of 1 for:    NCT01945034
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5% Topical Ibuprofen (IBU) for Ankle Sprain

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ClinicalTrials.gov Identifier: NCT01945034
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 21, 2013
First Posted Date  ICMJE September 18, 2013
Results First Submitted Date  ICMJE August 19, 2015
Results First Posted Date  ICMJE May 26, 2016
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
  • 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 Measures  ICMJE
 (submitted: September 13, 2013)
  • 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 ]
Change History Complete list of historical versions of study NCT01945034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
  • 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 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 5% Topical Ibuprofen (IBU) for Ankle Sprain
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ankle Injuries
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Topical IBU twice daily
    Intervention: Drug: Topical IBU twice daily
  • Placebo Comparator: Placebo twice daily
    Intervention: Drug: Placebo twice daily
  • Experimental: Topical IBU three times daily
    Intervention: Drug: Topical IBU three times daily
  • Placebo Comparator: Placebo three times daily
    Intervention: Drug: Placebo three times daily
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2016)
304
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)
340
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01945034
Other Study ID Numbers  ICMJE B3491009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP