Recruitment

Recruitment Status
Terminated

Inclusion Criteria

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 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 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 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 is male or female aged 18 to 70 years, inclusive.

Exclusion Criteria

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.
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.
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 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.

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 Criteria

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 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 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 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 is male or female aged 18 to 70 years, inclusive.

Exclusion Criteria

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.
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.
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 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.

Tracking Information

NCT #
NCT02089425
Collaborators
Not Provided
Investigators
Not Provided
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