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Antibiotic

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

Phase 2
Waitlist Available
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29

Summary

This trial tests a new form of the antibiotic rifaximin in people with sickle cell disease who have painful episodes. The treatment aims to change gut bacteria to help reduce pain and inflammation. About 60 participants will be involved, with some receiving the new treatment and others receiving a different substance.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Plasma Concentration

Side effects data

From 2023 Phase 2 trial • 44 Patients • NCT05098028
50%
Headache
38%
Abdominal discomfort
25%
Bacterial infection
25%
C-reactive protein increased
25%
Thrombocytosis
13%
White blood cell count increased
13%
Dermatitis
13%
Dizziness
13%
Dysmenorrhea
13%
Urine leukocyte esterase positive
13%
Puncture site pain
13%
Pain
13%
Hyperchlorhydria
13%
Syncope
13%
Non-cardiac chest pain
13%
Cough
13%
Blood lactate dehydrogenase increased
13%
Vomiting
13%
Fungal skin infection
13%
Hypochromic anemia
13%
Back pain
13%
Hypoxia
13%
Alanine aminotransferase increased
13%
Urine abnormality
13%
Oropharyngeal pain
13%
Fatigue
13%
Blood creatine phosphokinase increased
13%
Vulvovaginal rash
13%
Influenza
13%
Aspartate aminotransferase increased
13%
Muscle spasms
13%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Dose Rifaximin ER
Placebo
High Dose Rifaximin DER
Low Dose Rifaximin DER
Low Dose Rifaximin ER

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose Rifaximin ERExperimental Treatment1 Intervention
twice daily
Group II: Low Dose Rifaximin DERExperimental Treatment1 Intervention
twice daily
Group III: High Dose Rifaximin ERExperimental Treatment1 Intervention
twice daily
Group IV: High Dose Rifaximin DERExperimental Treatment1 Intervention
twice daily
Group V: PlaceboPlacebo Group1 Intervention
twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Dose Rifaximin DER
2022
Completed Phase 2
~50
Low Dose Rifaximin ER
2022
Completed Phase 2
~50
Low Dose Rifaximin DER
2022
Completed Phase 2
~50
High Dose Rifaximin ER
2022
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,872 Total Patients Enrolled
Anya LoncaricStudy DirectorBausch Health
39 Previous Clinical Trials
20,619 Total Patients Enrolled
Varsha BhattStudy DirectorBausch Health
8 Previous Clinical Trials
995 Total Patients Enrolled
~12 spots leftby Dec 2025
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