RECRUITING

Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).

Official Title

A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (PFI) (Also Known as Ledderhose Disease)

Quick Facts

Study Start:2023-11-28
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06151197

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be an ambulatory male or female ≥18 years of age.
  2. * Have a diagnosis of PFI.
  3. * Have current foot pain due to PFI.
  4. * Agree not to use prohibited medication, throughout the study, and not use any medication to treat PFI pain, except as permitted per the protocol.
  5. * If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
  6. * Be capable of providing consent, are adequately informed, and understand the nature and risks of the study.
  1. * Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
  2. * Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her foot and/or would impair his/her completion of study assessments as determined by the investigator.
  3. * Has any significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration or required assessments and evaluations.
  4. * Has a known bleeding disorder which would make the participant unsuitable for enrollment in the study.
  5. * Has a clinically significant laboratory abnormality.
  6. * Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being, or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for greater than 1 year and is judged by the investigator not to interfere with participation in the study, the participant may be included, with the documented approval of the medical monitor.
  7. * Has any other significant medical condition(s), which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
  8. * Is pregnant or plans to become pregnant.
  9. * Is breastfeeding or is providing or plans to provide breast milk in any manner during the study.

Contacts and Locations

Study Contact

Clinical Operations
CONTACT
800-462-3636
clinicaltrials@endo.com

Principal Investigator

Luis Ortega
STUDY_DIRECTOR
Endo Pharmaceuticals

Study Locations (Sites)

Endo Site 42
Mesa, Arizona, 85210
United States
Endo Site 11
Tucson, Arizona, 85712
United States
Endo Site 49
Castro Valley, California, 94546
United States
Endo Site 39
Cerritos, California, 90703
United States
Endo Site 31
Corona, California, 92882
United States
Endo Clinical Site 2
Encinitas, California, 92024
United States
Endo Site 8
Fresno, California, 93710
United States
Endo Site 28
Lancaster, California, 93534
United States
Endo Site 9
Los Angeles, California, 90010
United States
Endo Site 53
Los Angeles, California, 90063
United States
Endo Site 50
San Francisco, California, 94115
United States
Endo Site 29
Tarzana, California, 91356
United States
Endo Site 30
Tarzana, California, 91356
United States
Endo Site 47
Johnstown, Colorado, 80535
United States
Endo Site 17
Westminster, Colorado, 80031
United States
Endo Site 52
Washington, District of Columbia, 20036
United States
Endo Site 22
Hialeah, Florida, 33013
United States
Endo Site 19
Jupiter, Florida, 33458
United States
Endo Site 33
Medley, Florida, 33166
United States
Endo Site 23
Miami, Florida, 33126
United States
Endo Site 21
Miami, Florida, 33165
United States
Endo Site 35
North Miami Beach, Florida, 33169
United States
Endo Clinical Site 1
Pinellas Park, Florida, 33782
United States
Endo Site 14
Plantation, Florida, 33317
United States
Endo Site 26
South Miami, Florida, 33143
United States
Endo Site 24
Lawrenceville, Georgia, 30043
United States
Endo Site 27
O'Fallon, Illinois, 62269
United States
Endo Site 45
Oakbrook Terrace, Illinois, 60523
United States
Endo Site 54
Overland Park, Kansas, 66211
United States
Endo Site 56
Shreveport, Louisiana, 71101
United States
Endo Site 5
Pasadena, Maryland, 21122
United States
Endo Site 16
Grand Rapids, Michigan, 49525
United States
Endo Site 12
Jefferson City, Missouri, 65109
United States
Endo Site 51
Billings, Montana, 59101
United States
Endo Site 36
Missoula, Montana, 59804
United States
Endo Site 34
Westwood, New Jersey, 07675
United States
Endo Site 15
Durham, North Carolina, 27704
United States
Endo Site 20
Wilmington, North Carolina, 28412
United States
Endo Site 10
Altoona, Pennsylvania, 16602
United States
Endo Site 44
Malvern, Pennsylvania, 19355
United States
Endo Site 38
State College, Pennsylvania, 16801
United States
Endo Site 48
Arlington, Texas, 76015
United States
Endo Site 3
Bedford, Texas, 76021
United States
Endo Site 43
Burleson, Texas, 76028
United States
Endo Site 25
Dallas, Texas, 75208
United States
Endo Site32
Fort Worth, Texas, 76104
United States
Endo Site 7
Georgetown, Texas, 78628
United States
Endo Site 55
Houston, Texas, 77027
United States
Endo Site 40
Humble, Texas, 77338
United States
Endo Site 4
McAllen, Texas, 78501
United States
Endo Site 46
San Antonio, Texas, 78224
United States
Endo Site 18
San Antonio, Texas, 78258
United States
Endo Site 37
San Antonio, Texas, 78258
United States
Endo Site 41
Bountiful, Utah, 84010
United States
Endo Site 6
Salt Lake City, Utah, 84107
United States
Endo Site 13
Suffolk, Virginia, 23434
United States

Collaborators and Investigators

Sponsor: Endo Pharmaceuticals

  • Luis Ortega, STUDY_DIRECTOR, Endo Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-28
Study Completion Date2025-11

Study Record Updates

Study Start Date2023-11-28
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Plantar Fibromatosis
  • Ledderhose Disease