A Randomized, Double-blind, Placebo-controlled, Multi-dose, Pivotal Study to Determine the Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain.
Overview
- Phase
- Phase 3
- Intervention
- SST-0225 Topical Ibuprofen Cream
- Conditions
- Acute Ankle Sprain
- Sponsor
- Strategic Science & Technologies, LLC
- Enrollment
- 305
- Locations
- 1
- Primary Endpoint
- 24 Hour SPID
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose, parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all eligibility criteria, will be randomized into the study and will receive either the active treatment (SST-0225 ibuprofen cream), or matching placebo. Subjects will apply an amount equivalent to a 4 inch line of investigational product to the affected ankle approximately every 4-6 hours. At Visit 1 two doses will be applied at the site. All subsequent doses of the investigational product will be applied every 4 to 6 hours with a total of 4 doses in a 24 hour period. Duration of treatment with the investigational product is 7 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects ≥16 years of age
- •Grade I or II acute ankle sprain injury within 24 hours prior to first use of investigational product.
- •Grade I: when the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior drawer test is negative
- •Grade II: moderate sprain, which usually results in partial tears of the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling
- •At screening (Visit 1), subject reported pain intensity score upon movement of ≥ 5 on a 0-10 Numerical Rating Scale (NRS)
- •Subject's Assessment of Normal Function/Activity (must be \> 2) at screening
- •Able to comply with the visit schedule
- •Able to apply the investigational product as directed
- •Females of childbearing potential must be willing to use an approved method of birth control during study participation. Subjects currently using any of the below mentioned contraception methods, must have used the method for a minimum of three months prior to study enrollment, and must be willing to continue its use (at the same dose) throughout the study.
- •Effective methods of birth control: e.g. prescription oral, vaginal or transdermal contraceptives; contraceptive implants or injections; intrauterine device; diaphragm/cervical cap/condom with spermicide
Exclusion Criteria
- •Subjects meeting any of the following criteria will not be entered in the study:
- •Similar injury of the same joint within the last 6 months
- •Clinical evidence of complete rupture of ankle ligaments (third degree sprain)
- •Requirements for bed rest, hospitalization, or surgical intervention for the ankle injury
- •Evidence of fractures or non-removable full cast of any type
- •Presence of bilateral occurrence of ankle injury or ipsilateral ankle and/or knee injury
- •Open wound or infection at site of injury
- •Significant Skin irritation at the application site;
- •Use of longer half life NSAID within 12 hours prior to study entry (Appendix 4)
- •Does not agree to use only supplied investigational product and rescue medication for analgesia during the seven days of the study or expects to require analgesics during the study for pain other than for ankle pain
Arms & Interventions
Active
SST-0225 Topical Ibuprofen Cream (investigational product) Dose: 2.7 grams of cream containing 200 mg ibuprofen
Intervention: SST-0225 Topical Ibuprofen Cream
Placebo
Placebo topical formulation (Reference product)
Intervention: Placebo
Outcomes
Primary Outcomes
24 Hour SPID
Time Frame: 24 Hours
Tme weighted summed pain intensity on movement difference from baseline over the first 24 hours (SPID24) following the first application of study medication on Day 1
Secondary Outcomes
- Use of rescue medication including time to first use(7 days)
- Mean change from baseline in pain scores on movement(First 24 hours)
- Subject's global evaluation of investigational product(7 days)
- Change from baseline in pain scores on movement(7 days)
- Time to onset of confirmed perceptible pain relief and onset of meaningful pain relief(First 4 hours)
- Number and percent of patients with systemic and local (skin) self-reported adverse events(7 days)
- Mean change from baseline in subject reported pain intensity(First 4 hours)
- Percent of subjects with > 15%, > 30% and > 50% reductions in pain intensity(First 24 hours)