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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.
 
ClinicalTrials.gov Identifier: NCT02089425
Recruitment Status : Terminated (Interim futility analysis)
First Posted : March 17, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Study Description
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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

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02089425


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tempe, Arizona, United States
United States, California
Anaheim, California, United States
El Cajon, California, United States
Encinitas, California, United States
Los Angeles, California, United States
Ventura, California, United States
United States, Florida
Boynton Beach, Florida, United States
Daytona Beach, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Oldsmar, Florida, United States
Orlando, Florida, United States
Port Orange, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Kentucky
Owensboro, Kentucky, United States
United States, Maryland
Towson, Maryland, United States
United States, Michigan
Rochester, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Montana
Great Falls, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Atco, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Mooresville, North Carolina, United States
Morganton, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Willoughby, Ohio, United States
United States, Oregon
Gresham, Oregon, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Tennessee
Jackson, Tennessee, United States
Memphis, Tennessee, United States
Smyrna, Tennessee, United States
United States, Texas
Austin, Texas, United States
Boerne, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
United States, Utah
Bountiful, Utah, United States
Salt Lake City, Utah, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
More Information
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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02089425    
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
 Pain
Neurologic Manifestations
Leg Injuries