Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
NCT ID: NCT05152173
Last Updated: 2024-01-08
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
PHASE2
177 participants
INTERVENTIONAL
2021-11-29
2023-01-10
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
DOUBLE
Study Groups
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EN3835 Group
Participant will receive a maximum dose of up to 1.8mg of EN3835 injection
EN3835
Participant will receive a maximum dose of up to1.8mg of EN3835 injection
Placebo Group
Participant will receive a maximum dose of up to 1.8mg of Placebo injection
Placebo
Participant will receive a maximum dose of up to1.8mg of Placebo injection
Interventions
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EN3835
Participant will receive a maximum dose of up to1.8mg of EN3835 injection
Placebo
Participant will receive a maximum dose of up to1.8mg of Placebo injection
Eligibility Criteria
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Inclusion Criteria
2. Has no 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.
3. Agree not to use opioids during the study period and has not used opioids 2 weeks before the Screening 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. 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. Willing and able to comply with all protocol required visits and assessments.
7. Be adequately informed and understand the nature and risks of the study and be able to provide consent.
Exclusion Criteria
2. Has any musculoskeletal, neuromuscular, neurosensory, 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.
3. Has a known allergy to collagenase or any other excipient of EN3835.
4. 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.
5. 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. If there is a history of such disease and the condition has been stable for greater than one year and is judged by the investigator not to interfere, the participant may be included, with the documented approval of the Medical Monitor.
6. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
7. Has any other condition(s) that, in the investigator's opinion, might indicate the participants to be unsuitable for 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 #29
Mesa, Arizona, United States
Endo Clinical Trial Site #42
Tucson, Arizona, United States
Endo Clinical Trial Site #15
Bakersfield, California, United States
Endo Clinical Trial Site #41
Encinitas, California, United States
Endo Clinical Trial Site #9
Fresno, California, United States
Endo Clinical Trial Site #27
La Mesa, California, United States
Endo Clinical Trial Site #30
Los Angeles, California, United States
Endo Clinical Trial Site #12
Tarzana, California, United States
Endo Clinical Trial Site #36
Torrance, California, United States
Endo Clinical Trial Site #22
Vista, California, United States
Endo Clinical Trial Site #13
Whittier, California, United States
Endo Clinical Trial Site #16
Atlantis, Florida, United States
Endo Clinical Trial Site #43
Jacksonville, Florida, United States
Endo Clinical Trial Site #40
Miami, Florida, United States
Endo Clinical Trial Site #10
Pinellas Park, Florida, United States
Endo Clinical Trial Site #3
South Miami, Florida, United States
Endo Clinical Trial Site #14
Sweetwater, Florida, United States
Endo Clinical Trial Site #38
Lawrenceville, Georgia, United States
Endo Clinical Trial Site #31
Meridian, Idaho, United States
Endo Clinical Trial Site #32
Decatur, Illinois, United States
Endo Clinical Trial Site #19
O'Fallon, Illinois, United States
Endo Clinical Trial Site #33
Springfield, Illinois, United States
Endo Clinical Trial Site #23
Pasadena, Maryland, United States
Endo Clinical Trial Site #28
Jefferson City, Missouri, United States
Endo Clinical Trial Site #20
Las Vegas, Nevada, United States
Endo Clinical Trial Site #34
Oklahoma City, Oklahoma, United States
Endo Clinical Trial Site #4
York, Pennsylvania, United States
Endo Clinical Trial Site #35
Arlington, Texas, United States
Endo Clinical Trial Site #5
Bedford, Texas, United States
Endo Clinical Trial Site #24
Cedar Park, Texas, United States
Endo Clinical Trial Site #17
Dallas, Texas, United States
Endo Clinical Trial Site #2
Dallas, Texas, United States
Endo Clinical Trial Site #7
Fort Worth, Texas, United States
Endo Clinical Trial Site #39
Georgetown, Texas, United States
Endo Clinical Trial Site #25
Houston, Texas, United States
Endo Clinical Trial Site #8
Houston, Texas, United States
Endo Clinical Trial Site #1
McAllen, Texas, United States
Endo Clinical Trial Site #21
San Antonio, Texas, United States
Endo Clinical Trial Site #6
San Antonio, Texas, United States
Endo Clinical Trial Site #18
Salt Lake City, Utah, United States
Endo Clinical Trial Site #26
Lynchburg, Virginia, United States
Endo Clinical Trial Site #37
Midlothian, Virginia, United States
Endo Clinical Trial Site #11
Suffolk, Virginia, United States
Countries
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Other Identifiers
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EN3835-222
Identifier Type: -
Identifier Source: org_study_id
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