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Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief

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ClinicalTrials.gov Identifier: NCT01957215
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : June 15, 2015
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE October 4, 2013
First Posted Date  ICMJE October 8, 2013
Results First Submitted Date  ICMJE March 26, 2015
Results First Posted Date  ICMJE June 15, 2015
Last Update Posted Date June 15, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
Sum of Pain Intensity Difference (SPID)1-3 Days [ Time Frame: Baseline (Day 1) to Day 3 ]
SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1). Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents "No" and 10 represents the "worst possible pain"
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2013)
Sum of Pain Intensity Difference (SPID) [ Time Frame: From treatment Day 1 to Day 3 ]
Assessing efficacy of Indomethacin patch in comparison with placebo patch measured by SPID for pain on movement during the 48 hour time interval.
Change History Complete list of historical versions of study NCT01957215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
  • Pain Relief Score (PRS) on Movement Over Time [ Time Frame: 30 minutes (mins) to 144 hours (hrs) post treatment ]
    PRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.
  • NRS for Pain on Movement Over Time [ Time Frame: 30 mins to 144 hr post treatment ]
    NRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), patients were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
  • Change From Baseline in NRS at Rest [ Time Frame: Baseline (Day 1) to Day 7 ]
    Mean changes in pain intensity at each time point at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups at time points 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs was measured using NRS. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), participants were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
  • Time to Onset of Pain Relief [ Time Frame: Baseline (Day 1) to Day 3 ]
    Time to onset of pain relief was measured by the time to reach a pain relief score of "1" ("A little or perceptible pain relief").
  • Assessment of Sum of Pain Intensity Difference (SPID) on Movement [ Time Frame: Baseline (Day 1) to Day 7 ]
    SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1). Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents "No" and 10 represents the "worst possible pain".
  • Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement [ Time Frame: Baseline (Day 1) to Day 7 ]
    SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time; 0 hr (Day 1, pre treatment), 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [based on NRS which is a horizontal line with a scale from 0-10. where 0 represents "No" and 10 represents the "worst possible pain"]. NR scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]
  • Total Pain Relief (TOTPAR) on Movement [ Time Frame: Baseline (Day 1) to Day 7 ]
    TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, baseline), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Higher score indicated greater pain relief. TOTPARt = ∑PR x (time t - time t-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].
  • Patients' Global Assessment to Treatment [ Time Frame: Baseline (Day 1) to Day 14 ]
    Patients global assessment in response to treatment was measured at the end of the study on a scale of 0 to 4 where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent
  • Rate of Rescue Medication Use [ Time Frame: Baseline (Day 1) to Day 14 ]
    Rescue medication use was monitored throughout a period of 14 days.
  • Time to First Dose of Rescue Medication Use [ Time Frame: Baseline (Day 1) to Day 14 ]
    Rescue medication use was monitored throughout a period of 14 days.
  • Total Dose of Rescue Medication Use [ Time Frame: Baseline (Day 1) to Day 14 ]
    Rescue medication use was monitored throughout a period of 14 days.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2013)
  • Pain Relief Score (PRS) [ Time Frame: PRS to be assessed Day 1-end of study ]
    PRS to be assessed.
  • Numerical Rating Scale (NRS) for pain [ Time Frame: NRS on movement Day 1-end of study ]
    NRS for pain on movement (walking 5 steps on flat surface) to be assessed.
  • Change from baseline in NRS at rest [ Time Frame: NRS at rest Day1-Day7 ]
    Measuring the mean changes from baseline of NRS at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups.
  • Time to Onset of Pain Relief [ Time Frame: Day 1-2 ,Day 1-3, Day 1-7 ]
    Time to reach PRS=1; "A little or perceptible pain relief".
  • SPID [ Time Frame: Day 1-2 ,Day 1-3, Day 1-7 ]
    SPID (1-2days), SPID (1-7days) to be assessed.
  • Sum of Pain Intensity Difference and Pain Relief (SPRID) [ Time Frame: Day 1-2 ,Day 1-3, Day 1-7 ]
    SPRID to be assessed
  • Total Pain Relief (TOTPAR) [ Time Frame: Day 1-2 ,Day 1-3, Day 1-7 ]
    TOTPAR at treatment 1 to 2, 1 to 3, and 1 to 7 days time period between treatment groups.
  • Time to rescue medication [ Time Frame: Day 1 to Day 14 ]
    Rescue medication use to be monitored
  • Global Assessment [ Time Frame: End of study ]
    Global Assessment to be accessed
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief
Official Title  ICMJE A Clinical Study to Assess the Efficacy of Pain Relief of Topical Indomethacin Patch Over Placebo in Ankle Sprain Patients
Brief Summary This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch
Detailed Description Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which reduces pain, fever, stiffness and swelling in acute skeletal musculature injuries involving joints. However, oral Indomethacin formulations predisposes for some systemic side effects. To avoid the systemic side effects of oral Indomethacin, a topical Indomethacin formulations have been developed and approved in some countries as an Over the counter product. Present study is to investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankle Sprain
Intervention  ICMJE
  • Drug: Indomethacin
    Topical indomethacin
  • Drug: Placebo
    Placebo patch
Study Arms  ICMJE
  • Experimental: Indomethacin patch
    Indomethacin patch to be applied on the sprained ankle twice a day (BID).
    Intervention: Drug: Indomethacin
  • Placebo Comparator: Placebo patch
    Placebo patch to be applied on the sprained ankle BID.
    Intervention: Drug: Placebo
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: October 4, 2013)
270
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
  • Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.
  • Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm between injured and uninjured ankle)

Exclusion Criteria:

  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Participant who had medication that could interfere with the subject's perception of pain since experiencing ankle sprain.
  • Pregnancy , Breast Feeding and Substance Abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01957215
Other Study ID Numbers  ICMJE 202177
RH01778 ( Other Identifier: GSK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Rundo International Pharmaceutical Research & Development Co.,Ltd.
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2015

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