A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)

Last updated: October 25, 2024
Sponsor: Endo Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Soft Tissue Infections

Treatment

Placebo

EN3835

Clinical Study ID

NCT06169319
EN3835-227
  • Ages 18-75
  • All Genders

Study Summary

This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Have no significant medical history or examination findings related to the foot tobe treated, which in the investigator's opinion, would make the participantunsuitable for study intervention administration.

  • Have a diagnosis of plantar fasciitis for ≥6 months, which has not responded toconservative therapies. Conservative therapies may include rest, physical therapy,splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids,or nonsteroidal anti-inflammatory drugs (NSAIDs).

  • Have current foot pain due to plantar fasciitis.

Exclusion

Key Exclusion Criteria:

  • Has any musculoskeletal, neuromuscular, neurosensory, other neurological or relateddisorder that affects the participant's use of his/her feet and/or would impairhis/her completion of study assessments as determined by the investigator either dueto the disorder or due to pain.

  • Has a clinically meaningful laboratory abnormality.

  • Has a body mass index ≥35 kilograms per meter squared (kg/m^2).

  • Has a known bleeding disorder, which, in the investigator's opinion, would make theparticipant unsuitable for enrollment in the study.

Study Design

Total Participants: 231
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 12, 2023
Estimated Completion Date:
September 24, 2024

Connect with a study center

  • Endo Site 8

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Endo Site 20

    Castro Valley, California 94546
    United States

    Site Not Available

  • Endo Site 13

    Corona, California 92882
    United States

    Site Not Available

  • Endo Site 6

    Encinitas, California 92024
    United States

    Site Not Available

  • Endo Site 11

    Fresno, California 93710
    United States

    Site Not Available

  • Endo Site 16

    Los Angeles, California 90010
    United States

    Site Not Available

  • Endo Site 40

    Los Angeles, California 90063
    United States

    Site Not Available

  • Endo Site 21

    San Francisco, California 94115
    United States

    Site Not Available

  • Endo Site 10

    Tarzana, California 91356
    United States

    Site Not Available

  • Endo Site 37

    Coconut Creek, Florida 33073
    United States

    Site Not Available

  • Endo Clinical Site 3

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Endo Site 14

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Endo Site 7

    Lawrenceville, Georgia 30043
    United States

    Site Not Available

  • Endo Site 23

    Stonecrest, Georgia 30038
    United States

    Site Not Available

  • Endo Site 31

    North Chicago, Illinois 60064
    United States

    Site Not Available

  • Endo Site 28

    O'Fallon, Illinois 62269
    United States

    Site Not Available

  • Endo Site 33

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Endo Site 35

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Endo Clinical Site 2

    Pasadena, Maryland 21122
    United States

    Site Not Available

  • Endo Site 19

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • Endo Site 27

    Missoula, Montana 59804
    United States

    Site Not Available

  • Endo Site 38

    Westwood, New Jersey 07675
    United States

    Site Not Available

  • Endo Site 25

    Moore, Oklahoma 73160
    United States

    Site Not Available

  • Endo Site 39

    Portland, Oregon 97202
    United States

    Site Not Available

  • Endo Site 36

    Malvern, Pennsylvania 19355
    United States

    Site Not Available

  • Endo Clinical Site 4

    Bedford, Texas 76021
    United States

    Site Not Available

  • Endo Site 24

    Burleson, Texas 76028
    United States

    Site Not Available

  • Endo Site 17

    Dallas, Texas 75208
    United States

    Site Not Available

  • Endo Site 18

    Dallas, Texas 75251
    United States

    Site Not Available

  • Endo Site 26

    Dallas, Texas 75235
    United States

    Site Not Available

  • Endo Site 30

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Endo Clinical Site 1

    Georgetown, Texas 78628
    United States

    Site Not Available

  • Endo Site 15

    Houston, Texas 77027
    United States

    Site Not Available

  • Endo Site 9

    McAllen, Texas 78501
    United States

    Site Not Available

  • Endo Site 22

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Endo Site 34

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Endo Clinical Site 5

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Endo Site 32

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Endo Site 12

    Suffolk, Virginia 23434
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.