Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants with Minor Soft Tissue Injury

Last updated: December 5, 2024
Sponsor: IBSA Institut Biochimique SA
Overall Status: Completed

Phase

3

Condition

Pressure Ulcers

Sprains

Treatment

Licart™ (diclofenac epolamine) topical system

Clinical Study ID

NCT05171673
18US-FHp04
  • Ages 6-45
  • All Genders

Study Summary

A multi-center, prospective, open-label, controlled study of the pharmacokinetics and safety of the LicartTM topical system in pediatric and adult participants with minor soft tissue injuries. 150 male and female participants aged 6-16 and 18-45 with soft tissue injuries meeting the following criteria will be enrolled to evaluate the pharmacokinetics and safety of the Licart topical system in pediatric and adult participants with minor soft tissue injuries over a 14-day treatment course. The analgesic effects will also be evaluated of the topical system in pediatric and adult participants with minor soft tissue injuries over a 14-day treatment course. To collect principal investigator-reported global response to therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Willing to provide written informed consent;

  2. Male or female, 6-11 years old; 12-16 years old; or 18-45 years old;

  3. BMI <32kg/m2;

  4. Minor soft tissue injury within 96 hours of enrollment;

  5. Spontaneous pain of at least moderate intensity (i.e., pain of at least 6 on theWong-Baker FACES® scale) according to the participant);

  6. Clinically significant injury according to the principal investigator;

  7. Willing and able to accommodate study requirements for data collection, includingreturn for study Visits 2 and 5;

  8. Have access to high-speed internet, a computer, iPad, or android device fortelehealth visits;

  9. Negative urine pregnancy test at inclusion for females of reproductive potential (started the menstrual cycle);

  10. 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;

  11. 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

  12. Able to read and speak English.

Exclusion

Exclusion Criteria:

  1. 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);

  2. Open skin lesion or any dermatological condition (e.g., skin infection, eczema)within the injured area;

  3. Injury involves the spine, digits, hands, or bottom of foot;

  4. Prior injury to the same site within the past 90 days;

  5. Three or more other prior injuries (minor or major) to the region in the past;

  6. Injury occurred more than 96 hours prior to study entry;

  7. Prior use of topical medication to involved area within 48 hours of study entry;

  8. Hypersensitivity disorders, including asthma or urticaria, but only if associatedwith exposure to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) includingdiclofenac;

  9. Coagulation defects;

  10. 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);

  11. Prior use of narcotic analgesics within seven (7) days of study entry;

  12. Prior use of systemic anti-inflammatory steroidal drugs within 60 days of studyentry;

  13. Prior use of long-acting NSAIDs such as piroxicam or naproxen since injury;

  14. 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);

  15. Participants with mental, behavioral, or neurodevelopmental disorders for which therelevant disorder(s) prevent compliance with the protocol;

  16. Documented alcohol or drug abuse within 365 days of study entry;

  17. Documented nicotine dependence within 365 days of study entry;

  18. Current or prior history of severe cardiac, renal, or hepatic impairment or disease;

  19. Severe systemic diseases (e.g., cancer, severe acute infection);

  20. Any underlying disease or medication that severely compromises the participant'simmune system;

  21. Current or prior history of any chronic pain disorder;

  22. Current or prior history of gastrointestinal bleeds or, ulcers;

  23. Females who are pregnant or breast feeding; or

  24. Participation in another clinical trial within 90 days of enrollment.

Study Design

Total Participants: 151
Treatment Group(s): 1
Primary Treatment: Licart™ (diclofenac epolamine) topical system
Phase: 3
Study Start date:
October 31, 2021
Estimated Completion Date:
July 12, 2024

Study Description

Open-label, controlled study in pediatric and adult participants with minor soft tissue injuries. One-hundred fifty (150) participants between 6 and 11years old; 12 and 16 years old; and 18 and 45 years old will be enrolled, with equal numbers in each of the three age groups. The 50 adults enrolled will serve as the control. Participants will be seen by the principal investigator (PI) or designee at the clinical site, at entry and Visits 2 and 5 following the first topical system application, with the last visit scheduled on either Day 14 or the day after the participant experiences pain resolution. Visits 3 and 4 will be conducted via telehealth. At each study visit, adverse events (AEs) and concomitant medications will be recorded, local tolerability at the application site scored on a 7-point scale, and pain assessed by participants using the Wong-Baker FACES scale. Vital signs will be measured at the screening visit and Visits 2 and 5.

Participants will also assess pain twice daily (morning and evening) at home in the Participant Diary using the same Wong-Baker FACES scale. Blood samples will be obtained from each participant at Visit 2, 24 hours (± 1 hour) after initial topical system application at Visit 1, and at the time of study discontinuation (with a topical system in place) for determination of plasma diclofenac concentration and plasma activated partial thromboplastin time (aPTT). At the End-of-Study (EOS) Visit the principal investigator will provide an assessment of global response to therapy on a 5-point scale.

Participants will be asked to apply the Licart topical system once per day for a maximum of 14 days or until pain resolution, whichever occurs first.

This study will assess efficacy by the following assessments: Plasma diclofenac concentration, 24 hours (± 1 hour) after initial application (Visit 2) and EOS Visit; Pain score assessment by participant using the Wong-Baker FACES scale: every day (Participant Diary) and study visits on Visits 2, 3, 4 and 5; and Principal investigator assessment of global response to therapy on a 5-point scale.

This study will assess safety by the following assessments: Vital signs will be measured at the screening visit and Visit 2 and 5; AE reporting at each study visit; Local tolerability on a 7-point scale at Visits 2, 3, 4 and 5, or the day after pain resolution, with a topical system applied to the injured area; Plasma diclofenac concentration, 24 hours (±1 hour) after initial topical system application (Visit 2) and EOS Visit; and Plasma activated partial thromboplastin time (aPTT), 24 hours (±1 hour) after initial topical system application (Visit 2) and EOS Visit.

The primary endpoints of the study are: Diclofenac pharmacokinetic profile (Pediatric population vs Adult population; Two-sided 90% confidence interval (CI) <4 ng/mL); Local tolerability; AEs; and Activated partial thromboplastin time (aPTT).

The secondary endpoints of the study are: Participant-reported pain scores; Global response to therapy; and Vital signs.

All participants who receive at least one topical system will be subjected to classic safety and efficacy analyses. All participants who receive at least one topical system and have at least one blood draw to support determination of plasma diclofenac concentration will be subjected to the pharmacokinetic analysis. An evaluable participant population with adequate compliance and follow- up may also be analyzed.

Continuous variables will be presented as sample size, means, medians, standard deviations, range and 90% CI. Categorical variables will be presented as sample size, number of observations, percentages and exact 90% CI.

The participant population will be stratified by appropriate age categories and the effects of age may be analyzed using Analysis of Variance (ANOVA) or multiple regression methods.

Plasma diclofenac concentration in pediatric participants will be compared with those of adults using repeated measures mixed models (participants will have reached steady-state blood concentration by the time of the first blood draw).

Connect with a study center

  • Applied Research Center

    Little Rock, Arkansas 72212
    United States

    Site Not Available

  • Atella Clinical Research, LLC.

    La Palma, California 90623
    United States

    Site Not Available

  • Coastal Orthopedics and Research Department

    Bradenton, Florida 34209
    United States

    Site Not Available

  • University Clinical Research - Deland, LLC

    Deland, Florida 32720
    United States

    Site Not Available

  • ETNA Medical Center

    Fort Lauderdale, Florida 33321
    United States

    Site Not Available

  • My Community Research, Inc.

    Miami, Florida 33155
    United States

    Site Not Available

  • D & H Tamarac Research Centers, Inc.

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Research Integrity

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Safe Haven Clinical Research, Inc

    Raymond, Mississippi 39154
    United States

    Site Not Available

  • Safe Haven Clinical Research, Inc

    Vicksburg, Mississippi 39183
    United States

    Site Not Available

  • Ascendant Research Clinic, LLC.

    Alamogordo, New Mexico 88310
    United States

    Site Not Available

  • Prime Global Research Inc.

    Bronx, New York 10456
    United States

    Site Not Available

  • Smart Choice Clinical Research

    Tulsa, Oklahoma 74126
    United States

    Site Not Available

  • Center for Orthopaedics and Sports Medicine

    Indiana, Pennsylvania 15701
    United States

    Site Not Available

  • Ascendant Research Clinic, LLC.

    Marion, South Carolina 29571
    United States

    Site Not Available

  • Next Level Urgent Care

    Houston, Texas 77057
    United States

    Site Not Available

  • AIM Trials

    Plano, Texas 75093
    United States

    Site Not Available

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