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

NCT02324270 | Completed Phase 3 Results

• 1 other identifier: DICLO-13-01
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 31

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

Conditions

Ankle Sprain

Keywords

Pain due to ankle sprain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment

  Baseline, 3 days

Study Arms (3)

Diclofenac epolamine

ACTIVE COMPARATOR

Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)

Drug: Diclofenac epolamine

generic diclofenac epolamine patch

EXPERIMENTAL

Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)

Drug: Diclofenac epolamine

Placebo

PLACEBO COMPARATOR

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

Interventions

Diclofenac epolamine DRUG

Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain

Also known as: Flector Patch

Diclofenac epolamine; generic diclofenac epolamine patch

Placebo OTHER

Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain

Also known as: Vehicle control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Non pregnant females, 18-65 years of age
• Signed informed consent obtained that meets all criteria of current FDA and Health Insurance Portability and Accountability Act regulations
• Subject has a diagnosis of uncomplicated acute minor ankle sprain: Grade I and II (as defined by the America Academy of Orthopedic Surgeons AAOS)
• 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
• 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.
• 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.
• 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.
• Subject shows willingness and capability to cooperate to the extent and degree required by the protocol.
• Subject is willing to refrain from using any other pain medication during their participation.

You may not qualify if:

• Pregnant or breastfeeding female.
• Sprain occurred \> 48 hours prior to study enrollment.
• Ankle sprain requires an orthopedic or surgical treatment.
• Ankle sprain treated prior to study entry by topical, oral, or parenteral nonsteroidal antiinflammatory drug (NSAID), physiotherapy, ultrasound, physical therapy or acupuncture.
• Baseline self-evaluation of pain on active mobilization by the VAS \< 50 mm.
• Non-intact or damaged skin within the area to be treated, e.g., eczema, psoriasis, exudative, dermatitis, infected lesion, burn or wound.
• Medical history of asthma, urticaria, angioedema, bronchospasm, ulcer disease, gastrointestinal bleeding, hypertension, edema, heart failure or cardiovascular disease.
• Medical history of any chronic pain disorder.
• Coagulation defects.
• Severe cardiac, renal or hepatic impairment.
• Severe systemic disease (e.g., cancer, severe acute infection).
• Use within one month prior to randomization of 1.) immunomodulators or immunosuppressive therapies, 2.) interferon, 3.) oral or parenteral corticosteroids or 4.) cytotoxic drugs.
• Use within 7 days prior to randomization of any topical agents on the affected ankle.
• Use within 7 days prior to randomization of topical, oral or parenteral treatment with NSAIDs or aspirin.
• Use within 12 hours prior to randomization of an analgesic. Eg. Acetaminophen (Tylenol®).

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (31)

Site 21

Birmingham, Alabama, 35209, United States

Location

Site 24

Goodyear, Arizona, 85395, United States

Location

Site 08

Carlsbad, California, 92008, United States

Location

Site 05

Ventura, California, 93003, United States

Location

Site 16

Clinton, Connecticut, 84105, United States

Location

Site 03

Riverton, Connecticut, 84065, United States

Location

Site 11

Daytona Beach, Florida, 32117, United States

Location

Site 09

DeLand, Florida, 32720, United States

Location

Site 14

Miami, Florida, 33144, United States

Location

Site 07

Miami, Florida, 33155, United States

Location

Site 13

Miami, Florida, 33155, United States

Location

Site 02

West Palm Beach, Florida, 33409, United States

Location

Site 26

Lexington, Kentucky, 40509, United States

Location

Site 12

Gretna, Louisiana, 70056, United States

Location

Site 23

Kalamazoo, Michigan, 85395, United States

Location

Site 41

Traverse City, Michigan, 49684, United States

Location

Site 10

Omaha, Nebraska, 32117, United States

Location

Site 29

Berlin, New Jersey, 08009, United States

Location

Site 18

Brooklyn, New York, 11201, United States

Location

Site 19

Cincinnati, Ohio, 45246, United States

Location

Site 30

Columbus, Ohio, 43214, United States

Location

Site 35

Oklahoma City, Oklahoma, 73112, United States

Location

Site 37

Downingtown, Pennsylvania, 19355, United States

Location

Site 27

State College, Pennsylvania, 16801, United States

Location

Site 15

Austin, Texas, 78756, United States

Location

04

El Paso, Texas, 93003, United States

Location

Site 34

Houston, Texas, 77089, United States

Location

Site 36

Lake Jackson, Texas, 77566, United States

Location

Site 22

San Antonio, Texas, 78218, United States

Location

Site 31

Danville, Virginia, 24541, United States

Location

Site 06

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

diclofenac hydroxyethylpyrrolidine

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Senior Director, Global Gx Clinical R&D- PD/CE Studies
• Organization: Teva Pharmaceuticals USA, Inc

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Henry Lau, PhD

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 24, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 24, 2020
• Results First Posted: June 24, 2020

Record last verified: 2020-06

Locations

US (31)