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Trial record 4 of 453 for:    DICLOFENAC

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

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ClinicalTrials.gov Identifier: NCT02324270
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

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

Condition or disease Intervention/treatment Phase
Ankle Sprain Drug: Diclofenac epolamine Other: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Vehicle control




Primary Outcome Measures :
  1. Bioequivalence between test diclofenac epolamine patch and reference (Flector) patch in VAS score - changes from baseline [ Time Frame: 3 days ]
    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


Secondary Outcome Measures :
  1. Superiority of test diclofenac epolamine patch over placebo and of reference (Flector) patch over placebo in VAS score - changes from baseline [ Time Frame: 3 days ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324270


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Sponsors and Collaborators
Actavis Inc.
Investigators
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Study Director: Henry Lau, PhD Actavis Inc.

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Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT02324270     History of Changes
Other Study ID Numbers: DICLO-13-01
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014
Keywords provided by Actavis Inc.:
Pain due to ankle sprain
Additional relevant MeSH terms:
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Diclofenac
Diclofenac hydroxyethylpyrrolidine
Acute Pain
Sprains and Strains
Ankle Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action