Recruitment

Recruitment Status
Terminated

Inclusion Criterias

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.
Subject is male or female aged 18 to 70 years, inclusive.
Subject must provide informed consent before any study specific evaluation is performed.
...
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.
Subject is male or female aged 18 to 70 years, inclusive.
Subject must provide informed consent before any study specific evaluation is performed.
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.

Exclusion Criterias

Subject has received topical analgesic medication within 24 hours before the Screening visit.
Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
...
Subject has received topical analgesic medication within 24 hours before the Screening visit.
Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
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.

Summary

Conditions
Acute Pain From Ankle Sprain or Strain
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Inclusion Criterias

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.
Subject is male or female aged 18 to 70 years, inclusive.
Subject must provide informed consent before any study specific evaluation is performed.
...
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.
Subject is male or female aged 18 to 70 years, inclusive.
Subject must provide informed consent before any study specific evaluation is performed.
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.

Exclusion Criterias

Subject has received topical analgesic medication within 24 hours before the Screening visit.
Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
...
Subject has received topical analgesic medication within 24 hours before the Screening visit.
Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
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.

Locations

Memphis, Tennessee
Hialeah, Florida
Bountiful, Utah
Dayton, Ohio
Omaha, Nebraska
...
Memphis, Tennessee
Hialeah, Florida
Bountiful, Utah
Dayton, Ohio
Omaha, Nebraska
Jacksonville, Florida
El Paso, Texas
Miami, Florida
Orlando, Florida
Willoughby, Ohio
Austin, Texas
Port Orange, Florida
Doral, Florida
Birmingham, Alabama
Boerne, Texas
Houston, Texas
Atco, New Jersey
Columbus, Ohio
El Cajon, California
Morganton, North Carolina
New York, New York
Cincinnati, Ohio
Charlotte, North Carolina
Overland Park, Kansas
Great Falls, Montana
Las Vegas, Nevada
Anaheim, California
Chicago, Illinois
Encinitas, California
Jackson, Tennessee
Towson, Maryland
Smyrna, Tennessee
Mooresville, North Carolina
Tempe, Arizona
Phoenix, Arizona
Salt Lake City, Utah
Ventura, California
Daytona Beach, Florida
Rapid City, South Dakota
Boynton Beach, Florida
Owensboro, Kentucky
Los Angeles, California
St. Louis, Missouri
Rochester, Michigan
Oldsmar, Florida
Kissimmee, Florida
Gresham, Oregon

Tracking Information

NCT #
NCT02089425
Collaborators
Not Provided
Investigators
Not Provided