Clinical trial NCT02324270: Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Official title: Randomized, Double-Blind, Multiple-Center, Placebo-Controlled Study Comparing the Safety and Efficacy of Generic Diclofenac Epolamine to Flector® Patch in the Treatment of Acute Pain Due to Minor Ankle Sprain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankle Sprain
Keywords: Pain due to ankle sprain
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: To evaluate the therapeutic equivalence and safety of generic diclofenac epolamine 1.3% patch (Watson Laboratories, Inc.) and Flector® (diclofenac epolamine 1.3% patch) (Pfizer) in the treatment of acute pain due to minor ankle sprain.

To demonstrate the superiority of the efficacy of the test and reference products over that of the vehicle control in the treatment of acute pain due to minor ankle sprain.

To access application site reactions and patch adhesion between treatment groups.

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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
timeFrame: Baseline, 3 days
Secondary outcomes:
measure: Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
timeFrame: Baseline, 3 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 21
state: Alabama
city: Goodyear
country: United States
facility: Site 24
state: Arizona
city: Carlsbad
country: United States
facility: Site 08
state: California
city: Ventura
country: United States
facility: Site 05
state: California
city: Clinton
country: United States
facility: Site 16
state: Connecticut
city: Riverton
country: United States
facility: Site 03
state: Connecticut
city: Daytona Beach
country: United States
facility: Site 11
state: Florida
city: DeLand
country: United States
facility: Site 09
state: Florida
city: Miami
country: United States
facility: Site 14
state: Florida
city: Miami
country: United States
facility: Site 07
state: Florida
city: Miami
country: United States
facility: Site 13
state: Florida
city: West Palm Beach
country: United States
facility: Site 02
state: Florida
city: Lexington
country: United States
facility: Site 26
state: Kentucky
city: Gretna
country: United States
facility: Site 12
state: Louisiana
city: Kalamazoo
country: United States
facility: Site 23
state: Michigan
city: Traverse City
country: United States
facility: Site 41
state: Michigan
city: Omaha
country: United States
facility: Site 10
state: Nebraska
city: Berlin
country: United States
facility: Site 29
state: New Jersey
city: Brooklyn
country: United States
facility: Site 18
state: New York
city: Cincinnati
country: United States
facility: Site 19
state: Ohio
city: Columbus
country: United States
facility: Site 30
state: Ohio
city: Oklahoma City
country: United States
facility: Site 35
state: Oklahoma
city: Downingtown
country: United States
facility: Site 37
state: Pennsylvania
city: State College
country: United States
facility: Site 27
state: Pennsylvania
city: Austin
country: United States
facility: Site 15
state: Texas
city: El Paso
country: United States
facility: 04
state: Texas
city: Houston
country: United States
facility: Site 34
state: Texas
city: Lake Jackson
country: United States
facility: Site 36
state: Texas
city: San Antonio
country: United States
facility: Site 22
state: Texas
city: Danville
country: United States
facility: Site 31
state: Virginia
city: Newport News
country: United States
facility: Site 06
state: Virginia
Study officials:
affiliation: Actavis Inc.
name: Henry Lau, PhD
role: STUDY_DIRECTOR
References: