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NCT05254457 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis
A Phase 3 study of Plantar Fibromatosis, sponsored by Endo Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
- 20
- Study locations
NCT05254457: Completed Phase 3 study of Plantar Fibromatosis, sponsored by Endo Pharmaceuticals.
NCT05254457 is a Phase 3 study of Plantar Fibromatosis that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 145 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05254457, a Phase 3 study of Plantar Fibromatosis, has completed, sponsored by Endo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
- 20
- Study locations
Study 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 EN3835 in the treatment and retreatment of plantar fibromatosis.
Primary Outcome
Proportion of participants reporting AE during the study assessed by incidence, severity and duration
Conditions Studied
Interventions
- BIOLOGICAL EN3835
Study Locations (20)
California
- Endo Clinical Trial Site #12 - Bakersfield
- Endo Clinical Trial Site #3 - Fresno
- Endo Clinical Trial Site #23 - La Mesa
- Endo Clinical Trial Site #13 - Tarzana
- Endo Clinical Trial Site #15 - Vista
- Endo Clinical Trial Site #18 - Whittier
Florida
- Endo Clinical Trial Site #24 - Miami
- Endo Clinical Trial Site #8 - Pinellas Park
- Endo Clinical Trial Site #21 - Sweetwater
Illinois
- Endo Clinical Trial Site #19 - Decatur
- Endo Clinical Trial Site #2 - O'Fallon
- Endo Clinical Trial Site #14 - Springfield
Texas
- Endo Clinical Trial Site #4 - Bedford
- Endo Clinical Trial Site #17 - Dallas
- Endo Clinical Trial Site #26 - Dallas
Georgia
- Endo Clinical Trial Site #22 - Lawrenceville
Idaho
- Endo Clinical Trial Site #25 - Meridian
Maryland
- Endo Clinical Trial Site #6 - Pasadena
Missouri
- Endo Clinical Trial Site #16 - Jefferson City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2022-02-14 |
| Est. Completion | 2024-03-21 |
| Phase | Phase 3 |
What the finished NCT05254457 record still lists
NCT05254457 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Plantar Fibromatosis appearing as the primary indexed condition, and to 1 intervention - of which EN3835 is the first listed.
NCT05254457 names 20 study sites across 9 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05254457 about?
NCT05254457 is a clinical study titled "Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis". 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 EN3835 in the treatment and retreatment of plantar fibromatosis.
What is the current status of trial NCT05254457?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2022-02-14. Estimated completion is 2024-03-21.
What conditions does trial NCT05254457 study?
This clinical trial studies the following conditions: Plantar Fibromatosis.
What interventions are being tested in trial NCT05254457?
The interventions under investigation include: EN3835 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05254457?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05254457 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05254457's enrollment target sits among peer trials
145 1555th of 2000 higher than 442 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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