Study Stopped
Interim futility analysis
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.
1 other identifier
interventional
384
1 country
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2014
Shorter than P25 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 3, 2017
March 1, 2017
8 months
March 14, 2014
March 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Sum of Pain Intensity Difference(SPID) 0-72
72 Hours
Secondary Outcomes (1)
Mean change from Baseline in pain intensity difference (PID)
168 Hours
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo patch: 0% indomethacin
K-103-IP
EXPERIMENTALK-103-IP: 0.5% indomethacin
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
El Cajon, California, United States
Unknown Facility
Encinitas, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Ventura, California, United States
Unknown Facility
Boynton Beach, Florida, United States
Unknown Facility
Daytona Beach, Florida, United States
Unknown Facility
Doral, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Kissimmee, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Oldsmar, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Port Orange, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Owensboro, Kentucky, United States
Unknown Facility
Towson, Maryland, United States
Unknown Facility
Rochester, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Great Falls, Montana, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Atco, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Mooresville, North Carolina, United States
Unknown Facility
Morganton, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Willoughby, Ohio, United States
Unknown Facility
Gresham, Oregon, United States
Unknown Facility
Rapid City, South Dakota, United States
Unknown Facility
Jackson, Tennessee, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Smyrna, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Boerne, Texas, United States
Unknown Facility
El Paso, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Bountiful, Utah, United States
Unknown Facility
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2014
First Posted
March 17, 2014
Study Start
April 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 3, 2017
Record last verified: 2017-03