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NCT03526549 · ClinicalTrials.gov registry record · Phase 3
Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
A Phase 3 study of Cellulite and Edematous Fibrosclerotic Panniculopathy, sponsored by Endo Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 483
- Enrollment target
- 20
- Study locations
NCT03526549: Completed Phase 3 study of Cellulite and Edematous Fibrosclerotic Panniculopathy, sponsored by Endo Pharmaceuticals.
NCT03526549 is a Phase 3 study of Cellulite and Edematous Fibrosclerotic Panniculopathy that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 483 participants, above the 76-participant average among 5 other Cellulite trials with a reported enrollment target (536% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03526549, a Phase 3 study of Cellulite and Edematous Fibrosclerotic Panniculopathy, has completed, sponsored by Endo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 483 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum \[CCH\]-aaes) lasts in the treatment of Cellulite.
Primary Outcome
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is lo
Conditions Studied
Interventions
- OTHER Observation
- BIOLOGICAL CCH-aaes
Study Locations (20)
California
- Endo Clinical Trial Site #14 - Encinitas
- Endo Clinical Trial Site #9 - Long Beach
- Endo Clinical Trial Site #35 - Murrieta
- Endo Clinical Trial Site #42 - Newport Beach
- Endo Clinical Trial Site #17 - Oceanside
- Endo Clinical Trial Site #39 - San Diego
Florida
- Endo Clinical Trial Site #38 - Boca Raton
- Endo Clinical Trial Site #8 - Coral Gables
- Endo Clinical Trial Site #40 - Largo
- Endo Clinical Trial Site #27 - Miami
- Endo Clinical Trial Site #36 - Miami
Arizona
- Endo Clinical Trial Site #3 - Glendale
- Endo Clinical Trial Site #11 - Scottsdale
Arkansas
- Endo Clinical Trial Site #41 - North Little Rock
Colorado
- Endo Clinical Trial Site #23 - Greenwood Village
Georgia
- Endo Clinical Trial Site #20 - Snellville
Idaho
- Endo Clinical Trial Site #19 - Meridian
Illinois
- Endo Clinical Trial Site #34 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 483 participants |
| Start Date | 2018-04-26 |
| Est. Completion | 2021-10-08 |
| Phase | Phase 3 |
What the finished NCT03526549 record still lists
NCT03526549 is an interventional study that assigns participants to a tested intervention. The registered 483 participants enrollment target is mid-sized for trials with a published cap, above the 76-participant average among 5 other Cellulite trials with a reported enrollment target (536% higher).
The record links to 2 conditions, with Cellulite appearing as the primary indexed condition, and to 2 interventions - of which Observation is the first listed.
NCT03526549 names 20 study sites across 10 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03526549 about?
NCT03526549 is a clinical study titled "Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)". A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum \[CCH\]-aaes) lasts in the treatment of Cellulite.
What is the current status of trial NCT03526549?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 483 participants. The study started on 2018-04-26. Estimated completion is 2021-10-08.
What conditions does trial NCT03526549 study?
This clinical trial studies the following conditions: Cellulite, Edematous Fibrosclerotic Panniculopathy.
What interventions are being tested in trial NCT03526549?
The interventions under investigation include: Observation (OTHER), CCH-aaes (BIOLOGICAL).
Who is sponsoring clinical trial NCT03526549?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03526549 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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