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NCT04192487 · ClinicalTrials.gov registry record · Phase 4
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea
A Phase 4 study, sponsored by Napo Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT04192487 is a Phase 4 study that has completed, run by Napo Pharmaceuticals. The registered enrollment target is 17 participants.
The verdict
NCT04192487, a Phase 4 study, has completed, sponsored by Napo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of treatment with crofelemer (Mytesi), delayed release 125 mg tablets twice daily (BID) following one month of treatment. 2. The safety and tolerability of crofelemer, (Mytesi) delayed release 125 mg tablets BID in healthy (HIV-negative) volunteers and HIV+ patients following one month of treatment.
Interventions
- DRUG Crofelemer delayed-release tablets 125mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04192487
The ClinicalTrials.gov registry entry for NCT04192487 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Napo Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Crofelemer delayed-release tablets 125mg is the first listed.
NCT04192487 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04192487 about?
NCT04192487 is a clinical study titled "Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea". This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of treatment with crofelemer (Mytesi), delayed release 125 mg tablets twice...
What is the current status of trial NCT04192487?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2019-10-22. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT04192487?
The interventions under investigation include: Crofelemer delayed-release tablets 125mg (DRUG).
Who is sponsoring clinical trial NCT04192487?
This trial is sponsored by Napo Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
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