Clinical trial NCT02089425: An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Pain From Ankle Sprain or Strain
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Sum of Pain Intensity Difference(SPID) 0-72
timeFrame: 72 Hours
Secondary outcomes:
measure: Mean change from Baseline in pain intensity difference (PID)
timeFrame: 168 Hours
Other outcomes:
Locations:
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state: Alabama
city: Phoenix
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city: Tempe
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state: Arizona
city: Anaheim
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state: California
city: El Cajon
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state: California
city: Encinitas
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state: California
city: Los Angeles
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state: California
city: Ventura
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state: California
city: Boynton Beach
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state: Florida
city: Daytona Beach
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state: Florida
city: Doral
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city: Hialeah
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state: Florida
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state: Florida
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state: Florida
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state: Florida
city: Oldsmar
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city: Orlando
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state: Florida
city: Port Orange
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state: Florida
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state: Illinois
city: Overland Park
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state: Kansas
city: Owensboro
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state: Kentucky
city: Towson
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state: Maryland
city: Rochester
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state: Michigan
city: St. Louis
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state: Missouri
city: Great Falls
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city: Omaha
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state: Nebraska
city: Las Vegas
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state: Nevada
city: Atco
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state: New Jersey
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state: New York
city: Charlotte
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city: Mooresville
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city: Morganton
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city: Cincinnati
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city: Columbus
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city: Dayton
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state: Oregon
city: Rapid City
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city: Jackson
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city: Memphis
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state: Tennessee
city: Smyrna
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state: Tennessee
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city: Boerne
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state: Texas
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
Study officials:
References: