Ankle SprainPhase 3NCT02324270

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

A Phase 3 study testing Diclofenac epolamine in people with Ankle Sprain, run by Actavis Inc. at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Ankle Sprain
What is being tested?: Diclofenac epolamine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 658 participants
Where: 31 sitesUnited States
Study dates: May 2014to Dec 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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®).
Known allergy or hypersensitivity to diclofenac, aspirin or other NSAIDs, or any excipient in the test product or brand product (Flector).
History of uncontrolled chronic or acute concomitant disease which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results.

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

United States31 sites

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

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Ankle Sprain
Being tested: Diclofenac epolamine, Placebo
Keywords: Pain due to ankle sprain
Medical subject headings: Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diclofenac epolamineDrug
Also called Flector Patch
Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
PlaceboOther
Also called Vehicle control
Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain

Study groups in NCT02324270
Study group	Role	What they receive
Diclofenac epolamine	Active comparator	Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer) Receives: Drug: Diclofenac epolamine
generic diclofenac epolamine patch	Experimental	Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.) Receives: 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 Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 3 days

Secondary outcomes (1)

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' .
Measured: Baseline, 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Dec 2014

First posted24 Dec 2014 (estimated)
Study startMay 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ankle SprainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 658 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02324270
Sponsor's protocol ID: DICLO-13-01
Status last verified: Jun 2020
First submitted: 8 Dec 2014
Last updated: 24 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain

All Ankle Sprain trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02324270
Acronym / sponsor ID: DICLO-13-01
Conditions: Ankle Sprain
Keywords: Pain due to ankle sprain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 658 participants (actual)
Lead sponsor: Actavis Inc.Industry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 24 Dec 2014 (estimated)
Results: Posted 24 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Diclofenac epolamine	Active comparator	Drug: Diclofenac epolamineFlector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer)
generic diclofenac epolamine patch	Experimental	Drug: Diclofenac epolamineGeneric Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.)
Placebo	Placebo comparator	Other: PlaceboPlacebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diclofenac epolamineAlso: Flector PatchDiclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain	Drug	Diclofenac epolamine, generic diclofenac epolamine patch
PlaceboAlso: Vehicle controlTopical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain	Other	Placebo

Primary outcome

Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
Time frame: Baseline, 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. 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.

1 secondary outcome

Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment
Time frame: Baseline, 3 days

Results and safety

Results posted to the registry on 24 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diclofenac Epolamine Patch (Test Product)	218	213
Flector (Reference Product)	219	212
Placebo	221	216

Primary outcome: Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment

Time frame: Baseline, 3 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Diclofenac Epolamine Patch (Test Product) n = 180	Flector (Reference Product) n = 177
Baseline	68.56 (11.03)	69.03 (10.90)
72 Hours after Initial treatment	25.34 (17.35)	25.78 (18.50)
Change from Baseline	-43.22 (18.94)	-43.25 (20.71)

Diclofenac Epolamine Patch (Test Product) vs Flector (Reference Product): Ratio: 1.01 (90% CI 0.94 to 1.08)

Population analysed: Per Protocol Population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to 3 days (72 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diclofenac Epolamine Patch (Test Product)	0 of 214 (0%)	17 of 214 (7.9%)	0 of 214
Flector (Reference Product)	0 of 216 (0%)	20 of 216 (9.3%)	0 of 216
Placebo	0 of 217 (0%)	22 of 217 (10.1%)	0 of 217

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ankle Sprain

Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
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Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Henry Lau, PhD study director

Actavis Inc.

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diclofenac epolamine in people with Ankle Sprain, run by Actavis Inc. at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) Scores at Baseline and Post Treatment (time frame: Baseline, 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02324270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.