Phase
Condition
Pressure Ulcers
Sprains
Treatment
Licart™ (diclofenac epolamine) topical system
Clinical Study ID
Ages 6-45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willing to provide written informed consent;
Male or female, 6-11 years old; 12-16 years old; or 18-45 years old;
BMI <32kg/m2;
Minor soft tissue injury within 96 hours of enrollment;
Spontaneous pain of at least moderate intensity (i.e., pain of at least 6 on theWong-Baker FACES® scale) according to the participant);
Clinically significant injury according to the principal investigator;
Willing and able to accommodate study requirements for data collection, includingreturn for study Visits 2 and 5;
Have access to high-speed internet, a computer, iPad, or android device fortelehealth visits;
Negative urine pregnancy test at inclusion for females of reproductive potential (started the menstrual cycle);
For pediatric and adult females of reproductive potential (started the menstrualcycle): abstinence from sexual intercourse, or use of highly effective contraceptionfor at least 30 days prior to screening, and agreement to use such a method duringstudy participation and for three (3) days following the final topical systemapplication;
For pediatric and adult males of reproductive potential: abstinence from sexualintercourse, or use of condoms or other methods to ensure effective contraceptionwith partner during study participation and for three (3) days following the finaltopical system application; and
Able to read and speak English.
Exclusion
Exclusion Criteria:
Major soft tissue injury (fractures are only exclusionary if the injury isstabilized with a device, e.g., a hard cast, that cannot be removed to allow atopical system to be applied to the injured area);
Open skin lesion or any dermatological condition (e.g., skin infection, eczema)within the injured area;
Injury involves the spine, digits, hands, or bottom of foot;
Prior injury to the same site within the past 90 days;
Three or more other prior injuries (minor or major) to the region in the past;
Injury occurred more than 96 hours prior to study entry;
Prior use of topical medication to involved area within 48 hours of study entry;
Hypersensitivity disorders, including asthma or urticaria, but only if associatedwith exposure to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) includingdiclofenac;
Coagulation defects;
Prior use of over the counter (OTC) analgesics or short-acting NSAIDs (ibuprofen,ketoprofen) within 6 hours of study entry (acetaminophen permitted up until the timeof study entry);
Prior use of narcotic analgesics within seven (7) days of study entry;
Prior use of systemic anti-inflammatory steroidal drugs within 60 days of studyentry;
Prior use of long-acting NSAIDs such as piroxicam or naproxen since injury;
Concomitant use of drugs which may be susceptible to interactions with diclofenac,or affect safety if used concomitantly (e.g., serotonin-selective reuptakeinhibitors, lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin,methotrexate, quinolone antimicrobials, other NSAIDs, steroids and diuretics);
Participants with mental, behavioral, or neurodevelopmental disorders for which therelevant disorder(s) prevent compliance with the protocol;
Documented alcohol or drug abuse within 365 days of study entry;
Documented nicotine dependence within 365 days of study entry;
Current or prior history of severe cardiac, renal, or hepatic impairment or disease;
Severe systemic diseases (e.g., cancer, severe acute infection);
Any underlying disease or medication that severely compromises the participant'simmune system;
Current or prior history of any chronic pain disorder;
Current or prior history of gastrointestinal bleeds or, ulcers;
Females who are pregnant or breast feeding; or
Participation in another clinical trial within 90 days of enrollment.
Study Design
Study Description
Connect with a study center
Applied Research Center
Little Rock, Arkansas 72212
United StatesSite Not Available
Atella Clinical Research, LLC.
La Palma, California 90623
United StatesSite Not Available
Coastal Orthopedics and Research Department
Bradenton, Florida 34209
United StatesSite Not Available
University Clinical Research - Deland, LLC
Deland, Florida 32720
United StatesSite Not Available
ETNA Medical Center
Fort Lauderdale, Florida 33321
United StatesSite Not Available
My Community Research, Inc.
Miami, Florida 33155
United StatesSite Not Available
D & H Tamarac Research Centers, Inc.
Tamarac, Florida 33321
United StatesSite Not Available
Research Integrity
Owensboro, Kentucky 42303
United StatesSite Not Available
Safe Haven Clinical Research, Inc
Raymond, Mississippi 39154
United StatesSite Not Available
Safe Haven Clinical Research, Inc
Vicksburg, Mississippi 39183
United StatesSite Not Available
Ascendant Research Clinic, LLC.
Alamogordo, New Mexico 88310
United StatesSite Not Available
Prime Global Research Inc.
Bronx, New York 10456
United StatesSite Not Available
Smart Choice Clinical Research
Tulsa, Oklahoma 74126
United StatesSite Not Available
Center for Orthopaedics and Sports Medicine
Indiana, Pennsylvania 15701
United StatesSite Not Available
Ascendant Research Clinic, LLC.
Marion, South Carolina 29571
United StatesSite Not Available
Next Level Urgent Care
Houston, Texas 77057
United StatesSite Not Available
AIM Trials
Plano, Texas 75093
United StatesSite Not Available
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