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NCT03781791 · ClinicalTrials.gov registry record · Phase 2
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)
A Phase 2 study of Parkinson Disease and Constipation, sponsored by Enterin.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
- 20
- Study locations
NCT03781791: Completed Phase 2 study of Parkinson Disease and Constipation, sponsored by Enterin.
NCT03781791 is a Phase 2 study of Parkinson Disease and Constipation that has completed, run by Enterin. The registered enrollment target is 151 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03781791, a Phase 2 study of Parkinson Disease and Constipation, has completed, sponsored by Enterin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive placebo. \- Study Update- Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized 1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each group.
Primary Outcome
The number of treatment related adverse events as reported and assessed by NCI CTCAE v.4.3.
Conditions Studied
Interventions
- DRUG Placebo Treatment
- DRUG Active Investigational Treatment ENT-01
Study Locations (20)
Florida
- JEM Research Institute - Atlantis
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
- Elias Research - Floridian Research Institute - Miami
- Elias Research - Allied Biomedical Research Institute - Miami
- Pharmax Research of South Florida - Miami
- MEDSOL Clinical Research - Port Charlotte
- Parkinson's Disease Treatment Center of SWFL - Port Charlotte
- Intercoastal Medical Group - Sarasota
- University of South Florida - Tampa
California
- The Parkinson's and Movement Disorder Institute - Fountain Valley
- Neuro Pain Medical Center - Fresno
- Pacific Neuroscience Medical Group - Oxnard
- SC3 Research - Pasadena - Pasadena
- Trial Connections - Care Access Research, Santa Clarita - Santa Clarita
Connecticut
- Associated Neurologist of Southern CT - Fairfield
- Care Access Research, Norwich - Norwich
Arizona
- Banner Sun Health Research Institute - Sun City
Arkansas
- Clinical Trials, Inc. - Little Rock
Colorado
- Rocky Mountain Movement Disorders Center - Englewood
District of Columbia
- Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2018-12-10 |
| Est. Completion | 2021-12-14 |
| Phase | Phase 2 |
What the finished NCT03781791 record still lists
NCT03781791 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo Treatment is the first listed.
NCT03781791 names 20 study sites across 7 states, led by Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03781791 about?
NCT03781791 is a clinical study titled "Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)". This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated...
What is the current status of trial NCT03781791?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2018-12-10. Estimated completion is 2021-12-14.
What conditions does trial NCT03781791 study?
This clinical trial studies the following conditions: Parkinson Disease, Constipation.
What interventions are being tested in trial NCT03781791?
The interventions under investigation include: Placebo Treatment (DRUG), Active Investigational Treatment ENT-01 (DRUG).
Who is sponsoring clinical trial NCT03781791?
This trial is sponsored by Enterin, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03781791 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03781791's enrollment target sits among peer trials
151 53rd of 297 higher than 245 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease 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.
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