Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
- Conditions
- Plantar FibromatosisLedderhose Disease
- Registration Number
- NCT06151197
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 418
Key Inclusion Criteria:<br><br> - Be an ambulatory male or female =18 years of age.<br><br> - Have a diagnosis of PFI.<br><br> - Have current foot pain due to PFI.<br><br> - Agree not to use prohibited medication, throughout the study, and not use any<br> medication to treat PFI pain, except as permitted per the protocol.<br><br> - If female, be of non-childbearing potential (history of hysterectomy, bilateral<br> oophorectomy, bilateral tubal ligation, or postmenopausal with no history of<br> menstrual flow in the 12 months prior to the Screening Visit); or, if of<br> childbearing potential, be non-pregnant, non-lactating and agree to use effective<br> contraception when with a male partner for the duration of the study and for 28 days<br> after any active treatment period.<br><br> - Be capable of providing consent, are adequately informed, and understand the nature<br> and risks of the study.<br><br>Key Exclusion Criteria:<br><br> - Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma,<br> rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or<br> malignant soft tissue lesions of the foot or ankle).<br><br> - Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related<br> disorder that affects the participant's use of his or her foot and/or would impair<br> his/her completion of study assessments as determined by the investigator.<br><br> - Has any significant medical history or examination findings related to the<br> participant's plantar nodule(s), which in the investigator's opinion, would make the<br> participant unsuitable for study intervention administration or required assessments<br> and evaluations.<br><br> - Has a known bleeding disorder which would make the participant unsuitable for<br> enrollment in the study.<br><br> - Has a clinically significant laboratory abnormality.<br><br> - Has concurrent diseases that might interfere with the conduct of the study, confound<br> the interpretation of the study results or endanger the participant's well-being, or<br> any significant hematological, endocrine, cardiovascular, respiratory, renal,<br> hepatic, or gastrointestinal disease. If there is a history of such disease but the<br> condition has been stable for greater than 1 year and is judged by the investigator<br> not to interfere with participation in the study, the participant may be included,<br> with the documented approval of the medical monitor.<br><br> - Has any other significant medical condition(s), which in the investigator's opinion,<br> would make the participant unsuitable for enrollment in the study.<br><br> - Is pregnant or plans to become pregnant.<br><br> - Is breastfeeding or is providing or plans to provide breast milk in any manner<br> during the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS)
- Secondary Outcome Measures
Name Time Method Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score;Change from Baseline in the FFI Activity Limitation Subscale Score;Change from Baseline in the FFI Pain Subscale Score;Change from Baseline in the FFI Total Score;Number of Participants That Used Rescue Analgesic Medication;Amount of (milligrams [mg]) Rescue Analgesic Medication Used;Patient Global Impression of Change (PGIC) Foot Pain Score;Clinician Global Impression of Change (CGIC) Score;Subject Satisfaction Score;Change from Baseline in Nodule Consistency (Firmness);Change from Baseline in the Nodular Hardness of the Treated Nodules