Status:
COMPLETED
Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Plantar Fibromatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 (EN3835-222, NCT05152173) and assess the efficacy and safety of ...
Eligibility Criteria
Inclusion
- Have been enrolled and completed a sponsored-clinical study of EN3835 (for the EN3835-222 study, participants who completed the study are those that completed the Day 57 visit, were assessed for safety and received at least 1 dose of study intervention).
- Willing and able to comply with all protocol required visits and assessments.
- Agree not to use opioids during the study period and has not used opioids 2 weeks prior to the Observational Day 1 Visit.
- Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
- Willing and able to comply with all protocol required visits and assessments.
- Be adequately informed and understand the nature and risks of the study and be able to provide consent
- 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 Day 1 Visit), or, if of childbearing potential, be nonpregnant, 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.
- Have no significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.
Exclusion
- Has any musculoskeletal, neuromuscular, neurosensory, or other neurological or related disorder that affects the participant's use of his or her feet and/or would impair his/her completion of study assessments as determined by the investigator.
- Any other significant medical condition or had an SAE in the parent study which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
- Received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated.
- Has a known systemic allergy to collagenase or any other excipient of EN3835.
- Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study.
- Has significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.
- Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except \<150mg of aspirin daily, 7 days prior to first injection and for the duration of the study.
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2024
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT05254457
Start Date
February 14 2022
End Date
March 21 2024
Last Update
March 21 2025
Active Locations (27)
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1
Endo Clinical Trial Site #12
Bakersfield, California, United States, 19331
2
Endo Clinical Trial Site #3
Fresno, California, United States, 93710
3
Endo Clinical Trial Site #23
La Mesa, California, United States, 91942
4
Endo Clinical Trial Site #13
Tarzana, California, United States, 91356