Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
NCT ID: NCT05254457
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
145 participants
INTERVENTIONAL
2022-02-14
2024-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Observation Only Group
No interventions assigned to this group
Treated or Retreated Group
EN3835
Treatment or retreatment with EN3835
Interventions
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EN3835
Treatment or retreatment with EN3835
Eligibility Criteria
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Inclusion Criteria
2. Willing and able to comply with all protocol required visits and assessments.
3. Agree not to use opioids during the study period and has not used opioids 2 weeks prior to the Observational Day 1 Visit.
4. Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
5. Willing and able to comply with all protocol required visits and assessments.
6. Be adequately informed and understand the nature and risks of the study and be able to provide consent
7. 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.
8. 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 Criteria
2. 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.
3. Received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated.
4. Has a known systemic allergy to collagenase or any other excipient of EN3835.
5. Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study.
6. 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.
7. 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.
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Nina Green
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Endo Clinical Trial Site #12
Bakersfield, California, United States
Endo Clinical Trial Site #3
Fresno, California, United States
Endo Clinical Trial Site #23
La Mesa, California, United States
Endo Clinical Trial Site #13
Tarzana, California, United States
Endo Clinical Trial Site #15
Vista, California, United States
Endo Clinical Trial Site #18
Whittier, California, United States
Endo Clinical Trial Site #24
Miami, Florida, United States
Endo Clinical Trial Site #8
Pinellas Park, Florida, United States
Endo Clinical Trial Site #21
Sweetwater, Florida, United States
Endo Clinical Trial Site #22
Lawrenceville, Georgia, United States
Endo Clinical Trial Site #25
Meridian, Idaho, United States
Endo Clinical Trial Site #19
Decatur, Illinois, United States
Endo Clinical Trial Site #2
O'Fallon, Illinois, United States
Endo Clinical Trial Site #14
Springfield, Illinois, United States
Endo Clinical Trial Site #6
Pasadena, Maryland, United States
Endo Clinical Trial Site #16
Jefferson City, Missouri, United States
Endo Clinical Trial Site #9
York, Pennsylvania, United States
Endo Clinical Trial Site #4
Bedford, Texas, United States
Endo Clinical Trial Site #17
Dallas, Texas, United States
Endo Clinical Trial Site #26
Dallas, Texas, United States
Endo Clinical Trial Site #5
Fort Worth, Texas, United States
Endo Clinical Trial Site #27
Georgetown, Texas, United States
Endo Clinical Trial Site #7
Houston, Texas, United States
Endo Clinical Trial Site #10
Houston, Texas, United States
Endo Clinical Trial Site #1
McAllen, Texas, United States
Endo Clinical Trial Site #11
Salt Lake City, Utah, United States
Endo Clinical Trial Site #20
Suffolk, Virginia, United States
Countries
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Other Identifiers
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EN3835-306
Identifier Type: -
Identifier Source: org_study_id
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