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NCT04483479 · ClinicalTrials.gov registry record · Phase 2
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)
A Phase 2 study, sponsored by Enterin.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT04483479 is a Phase 2 study that was terminated before completion, run by Enterin. The registered enrollment target is 27 participants.
The verdict
NCT04483479, a Phase 2 study, was terminated before completion, sponsored by Enterin.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study will be conducted as an open-label safety follow-on to a multi-center, double-blind, randomized study. All subjects who participated in the randomized study will be offered participation in this unblinded, single-arm, safety study. Approximately 50 subjects will be entered into the study and ENT-01 will be administered daily in escalating doses followed by a fixed dose for 12 weeks. Each subject will participate for approximately 20 weeks; dosing duration will be approximately 14 weeks.
Interventions
- DRUG Active Investigational Treatment ENT-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-07-30 |
| Est. Completion | 2022-02-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04483479
The ClinicalTrials.gov registry entry for NCT04483479 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Enterin, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Active Investigational Treatment ENT-01 is the first listed.
NCT04483479 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04483479 about?
NCT04483479 is a clinical study titled "Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)". This study will be conducted as an open-label safety follow-on to a multi-center, double-blind, randomized study. All subjects who participated in the randomized study will be offered participation in this unblinded, single-arm, safety study. Approximately 50 subjects will be entered into the study ...
What is the current status of trial NCT04483479?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2020-07-30. Estimated completion is 2022-02-17.
What interventions are being tested in trial NCT04483479?
The interventions under investigation include: Active Investigational Treatment ENT-01 (DRUG).
Who is sponsoring clinical trial NCT04483479?
This trial is sponsored by Enterin, which has 3 total clinical trials registered on ClinicalTrials.gov.
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