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Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Strategic Science & Technologies, LLC
ClinicalTrials.gov Identifier:
NCT01874626
First received: October 11, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Acute Ankle Sprain
Drug: Placebo
Drug: SST-0225 Topical formulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Strategic Science & Technologies, LLC:

Primary Outcome Measures:
  • 24 Hour SPID [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time to onset of confirmed perceptible pain relief and onset of meaningful pain relief [ Time Frame: First 4 hours ] [ Designated as safety issue: No ]
    • Time to onset of confirmed perceptible pain relief and onset of meaningful pain relief over the four-hour in-office phase of the study.

  • Mean change from baseline in subject reported pain intensity [ Time Frame: First 4 hours ] [ Designated as safety issue: No ]
    • Mean change from baseline in subject reported pain intensity (at rest and on movement) and pain relief (on movement only) as assessed at 15 minutes, 30 minutes, and hourly up to 4 hours following the first application on Day 1.

  • Mean change from baseline in pain scores on movement [ Time Frame: First 24 hours ] [ Designated as safety issue: No ]
    • Mean change from baseline in pain scores on movement at hours 6, 8, 10, 12, 20 and 24 hours over the first 24 hours.

  • Percent of subjects with > 15%, > 30% and > 50% reductions in pain intensity [ Time Frame: First 24 hours ] [ Designated as safety issue: No ]
    • Percent of subjects with > 15%, > 30% and > 50% reductions in pain intensity from baseline at 24 hours.

  • Subject's global evaluation of investigational product [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    • Subject's global evaluation of investigational product evaluated at Days 2, 4 and 7 (or End-of-Study) based on a 5 point scale.

  • Use of rescue medication including time to first use [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    • Use of rescue medication including time to first use (first 12 hours), proportion of subjects using rescue and amount of rescue medication used.

  • Change from baseline in pain scores on movement [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    • Change from baseline in pain scores on movement at time of each dose on Days 2-7.

  • Number and percent of patients with systemic and local (skin) self-reported adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Number and percent of patients with systemic and local (skin) self-reported adverse events.


Enrollment: 305
Study Start Date: July 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active
SST-0225 Topical formulation (investigational product) Dose: 2.7 grams of cream containing 200 mg ibuprofen
Drug: Placebo
Placebo Comparator: Placebo
Placebo topical formulation (Reference product)
Drug: SST-0225 Topical formulation

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects ≥16 years of age
  2. Grade I or II acute ankle sprain injury within 24 hours prior to first use of investigational product.

    1. Grade I: when the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior drawer test is negative
    2. 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
  3. At screening (Visit 1), subject reported pain intensity score upon movement of ≥ 5 on a 0-10 Numerical Rating Scale (NRS)
  4. Subject's Assessment of Normal Function/Activity (must be > 2) at screening
  5. Able to comply with the visit schedule
  6. Able to apply the investigational product as directed
  7. 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.

    1. 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
    2. Other acceptable methods of birth control include: Postmenopausal or amenorrhea for one year, Surgically sterile (hysterectomy, tubal ligation, or oopherectomy), Premenarcheal
  8. Able to speak, read and comprehend English and record requested measurements as outlined in the protocol
  9. Subject must be able to read, understand, sign and date the informed consent document (and the subject assent form, if necessary) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial

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Exclusion Criteria:

Subjects meeting any of the following criteria will not be entered in the study:

  1. Similar injury of the same joint within the last 6 months
  2. Clinical evidence of complete rupture of ankle ligaments (third degree sprain)
  3. Requirements for bed rest, hospitalization, or surgical intervention for the ankle injury
  4. Evidence of fractures or non-removable full cast of any type
  5. Presence of bilateral occurrence of ankle injury or ipsilateral ankle and/or knee injury
  6. Open wound or infection at site of injury
  7. Significant Skin irritation at the application site;
  8. Use of longer half life NSAID within 12 hours prior to study entry (Appendix 4)
  9. 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
  10. Presence or history of allergy or intolerance to aspirin, NSAIDs, acetaminophen or any of the excipients in the investigational product (L-Arginine hydrochloride, Glyceryl Stearate, Cetyl Alcohol, Squalane, Xanthan Gum, Isopropyl Myristate, Oleic Acid, Propylene Glycol, Polysorbate -20)
  11. Medical conditions including: peptic ulcer disease; clinically important gastrointestinal, renal, or hepatic disease within the past 6 months; clinically significant cardiovascular disease not stable for the past 6 months; uncontrolled hypertension as indicated by systolic blood pressure greater than or equal to 160 mmHg or a diastolic blood pressure greater than or equal to 100 mm Hg; coagulation disorders or hematologic disease; history of seizures; or known, significant, pre-existing conditions that would affect the interpretation of any potential adverse reactions to the study medication
  12. Known alcohol abuse, drug dependency, or history of significant psychiatric illness within the past 12 months
  13. Females who are pregnant or lactating.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874626

Locations
United States, Connecticut
Ce3
Guilford,, Connecticut, United States, 06437
Sponsors and Collaborators
Strategic Science & Technologies, LLC
  More Information

No publications provided

Responsible Party: Strategic Science & Technologies, LLC
ClinicalTrials.gov Identifier: NCT01874626     History of Changes
Other Study ID Numbers: SST0225-US-010-001
Study First Received: October 11, 2012
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Strategic Science & Technologies, LLC:
acute ankle sprain
Grade I or Grade II

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014