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An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02089425
Recruitment Status : Terminated (Interim futility analysis)
First Posted : March 17, 2014
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Brief Summary:
This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.

Condition or disease Intervention/treatment Phase
Acute Pain From Ankle Sprain or Strain Drug: K-103-IP Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo patch: 0% indomethacin
Drug: Placebo
Placebo comparator

Experimental: K-103-IP
K-103-IP: 0.5% indomethacin
Drug: K-103-IP

Primary Outcome Measures :
  1. Sum of Pain Intensity Difference(SPID) 0-72 [ Time Frame: 72 Hours ]

Secondary Outcome Measures :
  1. Mean change from Baseline in pain intensity difference (PID) [ Time Frame: 168 Hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must provide informed consent before any study specific evaluation is performed.
  • Subject is male or female aged 18 to 70 years, inclusive.
  • Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the Screening visit.
  • Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest that is less than upon monopodal weight bearing.

Exclusion Criteria:

  • Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain.
  • Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
  • Subject has received topical analgesic medication within 24 hours before the Screening visit.
  • Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02089425

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Sponsors and Collaborators
Kowa Research Institute, Inc.

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Responsible Party: Kowa Research Institute, Inc. Identifier: NCT02089425     History of Changes
Other Study ID Numbers: K-103-IP-3.01US
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Acute Pain
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms
Leg Injuries