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Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease

NCT05098028 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-09-19

Study results available
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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.

Conditions

Interventions

DRUG

Low Dose Rifaximin ER

Low Dose Rifaximin Extended Release Twice Daily

DRUG

Low Dose Rifaximin DER

Low Dose Rifaximin Delayed Extended Release Twice Daily

DRUG

High Dose Rifaximin ER

High Dose Rifaximin Extended Release Twice Daily

DRUG

High Dose Rifaximin DER

High Dose Rifaximin Delayed Extended Release Twice Daily

DRUG

Placebo

Placebo Twice Daily

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Varsha Bhatt · Bausch Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2023-09-04
Completion
2023-09-04
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Kenya

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05098028 on ClinicalTrials.gov