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

Clinical Trial
Study Details
Enrollment
44
Interventions
Description

Low Dose Rifaximin Extended Release Twice Daily

Name
Low Dose Rifaximin ER
Type
Drug
Description

Low Dose Rifaximin Delayed Extended Release Twice Daily

Name
Low Dose Rifaximin DER
Type
Drug
Description

High Dose Rifaximin Extended Release Twice Daily

Name
High Dose Rifaximin ER
Type
Drug
Description

High Dose Rifaximin Delayed Extended Release Twice Daily

Name
High Dose Rifaximin DER
Type
Drug
Description

Placebo Twice Daily

Name
Placebo
Type
Drug
Phase
Phase 2
Status
COMPLETED
Study ID #
NCT05098028
Study Type
Interventional
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.

Study Overview
Conditions
Contacts and Locations
Locations
Facility

Bausch Site 105
Orange, California 92868
United States

GeoPoint
33.78779, -117.85311
Facility

Bausch Site 103
Denver, Colorado 80220
United States

GeoPoint
39.73915, -104.9847
Facility

Bausch Site 104
Atlanta, Georgia 30329
United States

GeoPoint
33.749, -84.38798
Facility

Bausch Site 101
Syracuse, New York 13210
United States

GeoPoint
43.04812, -76.14742
Facility

Bausch Site 102
Greenville, North Carolina 27834
United States

GeoPoint
35.61266, -77.36635
Facility

Bausch Site 201
Montreal Quebec H2X 3E4
Canada

GeoPoint
45.50884, -73.58781
Facility

Bausch Site 501
Eldoret
30100
Kenya

GeoPoint
0.52036, 35.26993
Facility

Bausch Site 502
Kisumu
40100
Kenya

GeoPoint
-0.10221, 34.76171