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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: Completed Phase 2 study, sponsored by Bausch Health Americas.

NCT05098028 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Maximum observed plasma concentration

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

FieldValue
Enrollment Target 44 participants
Start Date 2022-03-22
Est. Completion 2023-09-04
Phase Phase 2
Bausch Health Americas

168 total trials

What the finished NCT05098028 record still lists

NCT05098028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT05098028 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05098028's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05098028, the US trial registry maintained by the National Library of Medicine. NCT05098028 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.