Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain

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

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

Study Overview

• Status: Completed
• Conditions: Ankle Sprain
• Intervention / Treatment: Drug: Diclofenac epolamine; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 658
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Site 21
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Site 24
  • California
    • Carlsbad, California, United States, 92008
      • Site 08
    • Ventura, California, United States, 93003
      • Site 05
  • Connecticut
    • Clinton, Connecticut, United States, 84105
      • Site 16
    • Riverton, Connecticut, United States, 84065
      • Site 03
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Site 11
    • DeLand, Florida, United States, 32720
      • Site 09
    • Miami, Florida, United States, 33144
      • Site 14
    • Miami, Florida, United States, 33155
      • Site 07
    • Miami, Florida, United States, 33155
      • Site 13
    • West Palm Beach, Florida, United States, 33409
      • Site 02
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Site 26
  • Louisiana
    • Gretna, Louisiana, United States, 70056
      • Site 12
  • Michigan
    • Kalamazoo, Michigan, United States, 85395
      • Site 23
    • Traverse City, Michigan, United States, 49684
      • Site 41
  • Nebraska
    • Omaha, Nebraska, United States, 32117
      • Site 10
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Site 29
  • New York
    • Brooklyn, New York, United States, 11201
      • Site 18
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Site 19
    • Columbus, Ohio, United States, 43214
      • Site 30
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Site 35
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19355
      • Site 37
    • State College, Pennsylvania, United States, 16801
      • Site 27
  • Texas
    • Austin, Texas, United States, 78756
      • Site 15
    • El Paso, Texas, United States, 93003
      • 04
    • Houston, Texas, United States, 77089
      • Site 34
    • Lake Jackson, Texas, United States, 77566
      • Site 36
    • San Antonio, Texas, United States, 78218
      • Site 22
  • Virginia
    • Danville, Virginia, United States, 24541
      • Site 31
    • Newport News, Virginia, United States, 23606
      • Site 06

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diclofenac epolamine; Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)	Drug: Diclofenac epolamine; Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain; Other Names: Flector Patch
Experimental: generic diclofenac epolamine patch; Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)	Drug: Diclofenac epolamine; Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain; Other Names: Flector Patch
Placebo Comparator: Placebo; Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine	Other: Placebo; Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain; Other Names: Vehicle control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment	To evaluate the therapeutic equivalence (90% CI) of generic diclofenac epolamine 1.3% patch (Watson Laboratories, Inc.) and Flector® (diclofenac epolamine 1.3% patch) (Pfizer) using a 100mm VAS scoring in the treatment of acute pain due to minor ankle sprain (in the per protocol population); changes from baseline. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as lower values of 'no pain at all' and higher values relating to 'pain as bad as it could be' . Percent improvement in VAS score is the percentage part of - change from baseline in VAS / Baseline VAS.	Baseline, 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment	To demonstrate the superiority (P<0.05) of the efficacy of the test and reference products over that of the vehicle control in the treatment of acute pain utilizing a 100 mm VAS (in the mITT population) - changes from baseline. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as lower values of 'no pain at all' and higher values relating to 'pain as bad as it could be' .	Baseline, 3 days

Collaborators and Investigators

• Sponsor: Actavis Inc.
• Investigators: Study Director: Henry lau, PhD, Actavis Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Pain due to ankle sprain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Acute Pain; Sprains and Strains; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac; Diclofenac hydroxyethylpyrrolidine
• Other Study ID Numbers: DICLO-13-01