An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
Inclusion Criteria
- 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.
- 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.
- 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 must provide informed consent before any study specific evaluation is performed.
Exclusion Criteria
- Subject has applied ice or compression to the injured area within 2 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 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 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 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 Criteria
- 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.
- 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.
- 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 must provide informed consent before any study specific evaluation is performed.
Exclusion Criteria
- Subject has applied ice or compression to the injured area within 2 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 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 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 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.
Tracking Information
- NCT #
- NCT02089425
- Collaborators
- Not Provided
- Investigators
- Not Provided