Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Acute Pain; Sprains and Strains; Ankle Injuries
Intervention: Diclofenac epolamine; Placebo
Intervention description: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain; Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 658.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain due to ankle sprain

Summary:

      To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against
      Flector patch in the treatment of pain in subjects with minor ankle sprain
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Non pregnant females, 18-65 years of age

          2. Signed informed consent obtained that meets all criteria of current FDA and Health
             Insurance Portability and Accountability Act regulations

          3. Subject has a diagnosis of uncomplicated acute minor ankle sprain: Grade I and II (as
             defined by the America Academy of Orthopedic Surgeons AAOS)

          4. Ankle sprain must have occurred < 48 hours before study entry with baseline pain score
             of > 50 mm on a 100 mm Visual Analog Scale (VAS) upon active mobilization

          5. Female subjects of childbearing potential (excluding women who are surgically
             sterilized or postmenopausal for at least 1 year), in addition to having a negative
             urine pregnancy test, must be willing to use an acceptable form of birth control
             during the study from the day of the first dose administration to 30 days after the
             last administration of study drug. For the purpose of this study the following are
             considered acceptable methods of birth control: oral or injectable contraceptives,
             contraceptive patches, Depo-Provera® (on stable treatment for at least 3 months)
             NuvaRing® (vaginal contraceptive); Implanon™ (contraceptive implant) double barrier
             methods (e.g. condom and spermicide), intrauterine device, or abstinence with a 2nd
             acceptable method of birth control, should the patient become sexually active. A
             sterile sexual partner is NOT considered an adequate form of birth control.

          6. All male subjects must agree to use accepted methods of birth control with their
             partners, from the day of the first dose administration to 30 days after the last
             administration of study drug. Abstinence is an acceptable method of birth control.
             Female partners should use an acceptable method of birth control as described in Item
             Number 5.

          7. Subject is free from any systemic or dermatologic disorder that, in the opinion of the
             investigator, will interfere with the study results or increase the risk of adverse
             events.

          8. Subject shows willingness and capability to cooperate to the extent and degree
             required by the protocol.

          9. Subject is willing to refrain from using any other pain medication during their
             participation.

        Exclusion Criteria:

          1. Pregnant or breastfeeding female.

          2. Sprain occurred > 48 hours prior to study enrollment.

          3. Ankle sprain requires an orthopedic or surgical treatment.

          4. Ankle sprain treated prior to study entry by topical, oral, or parenteral nonsteroidal
             antiinflammatory drug (NSAID), physiotherapy, ultrasound, physical therapy or
             acupuncture.

          5. Baseline self-evaluation of pain on active mobilization by the VAS < 50 mm.

          6. Non-intact or damaged skin within the area to be treated, e.g., eczema, psoriasis,
             exudative, dermatitis, infected lesion, burn or wound.

          7. Medical history of asthma, urticaria, angioedema, bronchospasm, ulcer disease,
             gastrointestinal bleeding, hypertension, edema, heart failure or cardiovascular
             disease.

          8. Medical history of any chronic pain disorder.

          9. Coagulation defects.

         10. Severe cardiac, renal or hepatic impairment.

         11. Severe systemic disease (e.g., cancer, severe acute infection).

         12. Use within one month prior to randomization of 1.) immunomodulators or
             immunosuppressive therapies, 2.) interferon, 3.) oral or parenteral corticosteroids or
             4.) cytotoxic drugs.

         13. Use within 7 days prior to randomization of any topical agents on the affected ankle.

         14. Use within 7 days prior to randomization of topical, oral or parenteral treatment with
             NSAIDs or aspirin.

         15. Use within 12 hours prior to randomization of an analgesic. Eg. Acetaminophen
             (Tylenol®).

         16. Known allergy or hypersensitivity to diclofenac, aspirin or other NSAIDs, or any
             excipient in the test product or brand product (Flector).

         17. History of uncontrolled chronic or acute concomitant disease which, in the
             Investigator's opinion, would contraindicate study participation or confound
             interpretation of the results.