Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankle Sprain
Intervention: Diclofenac epolamine (Drug); Placebo (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Actavis Inc. Official(s) and/or principal investigator(s): Henry Lau, PhD, Study Director, Affiliation: Actavis Inc.
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Bioequivalence between test diclofenac epolamine patch and reference (Flector) patch in VAS score - changes from baseline
Secondary outcome: Superiority of test diclofenac epolamine patch over placebo and of reference (Flector) patch over placebo in VAS score - changes from baseline
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Site 21, Birmingham, Alabama 35209, United States
Site 24, Goodyear, Arizona 85395, United States
Site 08, Carlsbad, California 92008, United States
Site 05, Ventura, California 93003, United States
Site 16, Clinton, Connecticut 84105, United States
Site 03, Riverton, Connecticut 84065, United States
Site 11, Daytona, Florida 32117, United States
Site 09, DeLand, Florida 32720, United States
Site 07, Miami, Florida 33155, United States
Site 13, Miami, Florida 33155, United States
Site 14, Miami, Florida 33144, United States
Site 02, West Palm Beach, Florida 33409, United States
Site 26, Lexington, Kentucky 40509, United States
Site 12, Gretna, Louisiana 70056, United States
Site 23, Kalamazoo, Michigan 85395, United States
Site 41, Traverse City, Michigan 49684, United States
Site 10, Omaha, Nebraska 32117, United States
Site 29, Berlin, New Jersey 08009, United States
Site 18, Brooklyn, New York 11201, United States
Site 19, Cincinnati, Ohio 45246, United States
Site 30, Columbus, Ohio 43214, United States
Site 35, Oklahoma City, Oklahoma 73112, United States
Site 37, Downingtown, Pennsylvania 19355, United States
Site 27, State College, Pennsylvania 16801, United States
Site 15, Austin, Texas 78756, United States
04, El Paso, Texas 93003, United States
Site 34, Houston, Texas 77089, United States
Site 36, Lake Jackson, Texas 77566, United States
Site 22, San Antonio, Texas 78218, United States
Site 31, Danville, Virginia 24541, United States
Site 06, Newport News, Virginia 23606, United States
Additional Information
Starting date: May 2014
Last updated: December 19, 2014
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