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NCT05098028 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT05098028 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 44 participants.
The verdict
NCT05098028, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled study in sickle cell disease participants with a history of Vaso-occlusive Crises (VOCs). Approximately 60 participants with sickle cell disease will be enrolled and randomized: 12 participants in each of four active novel formulation rifaximin groups and 6 participants in each of 2 placebo groups.
Interventions
- DRUG Placebo
- DRUG Low Dose Rifaximin ER
- DRUG Low Dose Rifaximin DER
- DRUG High Dose Rifaximin ER
- DRUG High Dose Rifaximin DER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2023-09-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05098028
The ClinicalTrials.gov registry entry for NCT05098028 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT05098028 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05098028 about?
NCT05098028 is a clinical study titled "Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease". This is a randomized, double-blind, placebo-controlled study in sickle cell disease participants with a history of Vaso-occlusive Crises (VOCs). Approximately 60 participants with sickle cell disease will be enrolled and randomized: 12 participants in each of four active novel formulation rifaximin ...
What is the current status of trial NCT05098028?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2022-03-22. Estimated completion is 2023-09-04.
What interventions are being tested in trial NCT05098028?
The interventions under investigation include: Placebo (DRUG), Low Dose Rifaximin ER (DRUG), Low Dose Rifaximin DER (DRUG), High Dose Rifaximin ER (DRUG), High Dose Rifaximin DER (DRUG).
Who is sponsoring clinical trial NCT05098028?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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