Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease (NCT NCT05098028)

NCT ID: NCT05098028

Last Updated: 2024-09-19

Results Overview

Maximum observed plasma concentration

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: Day 29
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Low Dose Rifaximin ER twice daily Low Dose Rifaximin ER: Low Dose Rifaximin Extended Release Twice Daily	High Dose Rifaximin ER twice daily High Dose Rifaximin ER: High Dose Rifaximin Extended Release Twice Daily	Low Dose Rifaximin DER twice daily Low Dose Rifaximin DER: Low Dose Rifaximin Delayed Extended Release Twice Daily	High Dose Rifaximin DER twice daily High Dose Rifaximin DER: High Dose Rifaximin Delayed Extended Release Twice Daily	Placebo twice daily Placebo: Placebo Twice Daily
Overall Study STARTED	7	8	11	9	9
Overall Study COMPLETED	7	8	11	9	8
Overall Study NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Low Dose Rifaximin ER n=7 Participants twice daily Low Dose Rifaximin ER: Low Dose Rifaximin Extended Release Twice Daily	High Dose Rifaximin ER n=8 Participants twice daily High Dose Rifaximin ER: High Dose Rifaximin Extended Release Twice Daily	Low Dose Rifaximin DER n=11 Participants twice daily Low Dose Rifaximin DER: Low Dose Rifaximin Delayed Extended Release Twice Daily	High Dose Rifaximin DER n=9 Participants twice daily High Dose Rifaximin DER: High Dose Rifaximin Delayed Extended Release Twice Daily	Placebo n=9 Participants twice daily Placebo: Placebo Twice Daily	Total n=44 Participants Total of all reporting groups
Age, Continuous	23.0 years STANDARD_DEVIATION 3.74 • n=5 Participants	24.6 years STANDARD_DEVIATION 4.17 • n=7 Participants	29.3 years STANDARD_DEVIATION 10.54 • n=5 Participants	22.6 years STANDARD_DEVIATION 4.16 • n=4 Participants	25.8 years STANDARD_DEVIATION 5.93 • n=21 Participants	25.3 years STANDARD_DEVIATION 6.85 • n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	23 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	37 Participants n=8 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 29

Population: Pharmacokinetic population included all participants who took at least 1 dose of active study treatment and had at least 1 blood sample collected and analyzed for at least 1 quantifiable plasma concentration for rifaximin and/or 25-desacetyl rifaximin without significant protocol violations or events with potential to affect the PK concentrations.

Maximum observed plasma concentration

Outcome measures

Measure	Low Dose Rifaximin ER n=5 Participants twice daily Low Dose Rifaximin ER: Low Dose Rifaximin Extended Release Twice Daily	High Dose Rifaximin ER n=6 Participants twice daily High Dose Rifaximin ER: High Dose Rifaximin Extended Release Twice Daily	Low Dose Rifaximin DER n=7 Participants twice daily Low Dose Rifaximin DER: Low Dose Rifaximin Delayed Extended Release Twice Daily	High Dose Rifaximin DER n=5 Participants twice daily High Dose Rifaximin DER: High Dose Rifaximin Delayed Extended Release Twice Daily	Placebo twice daily Placebo: Placebo Twice Daily
Maximum Plasma Concentration	0.5835 ng/mL Geometric Coefficient of Variation 86.3	0.7425 ng/mL Geometric Coefficient of Variation 58.4	0.2186 ng/mL Geometric Coefficient of Variation 124.0	0.7128 ng/mL Geometric Coefficient of Variation 50.1	—

Adverse Events

Low Dose Rifaximin ER

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

High Dose Rifaximin ER

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Low Dose Rifaximin DER

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

High Dose Rifaximin DER

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Low Dose Rifaximin ER n=7 participants at risk twice daily Low Dose Rifaximin ER: Low Dose Rifaximin Extended Release Twice Daily	High Dose Rifaximin ER n=8 participants at risk twice daily High Dose Rifaximin ER: High Dose Rifaximin Extended Release Twice Daily	Low Dose Rifaximin DER n=11 participants at risk twice daily Low Dose Rifaximin DER: Low Dose Rifaximin Delayed Extended Release Twice Daily	High Dose Rifaximin DER n=9 participants at risk twice daily High Dose Rifaximin DER: High Dose Rifaximin Delayed Extended Release Twice Daily	Placebo n=9 participants at risk twice daily Placebo: Placebo Twice Daily
Blood and lymphatic system disorders Anemia	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
General disorders Pyrexia	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Malaria	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Pneumonia	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Sepsis	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Pregnancy, puerperium and perinatal conditions Abortion complete	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.

Other adverse events

Measure	Low Dose Rifaximin ER n=7 participants at risk twice daily Low Dose Rifaximin ER: Low Dose Rifaximin Extended Release Twice Daily	High Dose Rifaximin ER n=8 participants at risk twice daily High Dose Rifaximin ER: High Dose Rifaximin Extended Release Twice Daily	Low Dose Rifaximin DER n=11 participants at risk twice daily Low Dose Rifaximin DER: Low Dose Rifaximin Delayed Extended Release Twice Daily	High Dose Rifaximin DER n=9 participants at risk twice daily High Dose Rifaximin DER: High Dose Rifaximin Delayed Extended Release Twice Daily	Placebo n=9 participants at risk twice daily Placebo: Placebo Twice Daily
Blood and lymphatic system disorders Anemia	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Blood and lymphatic system disorders Hypochromic anemia	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Blood and lymphatic system disorders Iron deficiency anemia	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Blood and lymphatic system disorders Thrombocytosis	28.6% 2/7 • 28 days of treatment and 2 weeks of follow-up.	25.0% 2/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Ear and labyrinth disorders Tinnitus	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Eye disorders Eye pruritus	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Abdominal discomfort	57.1% 4/7 • 28 days of treatment and 2 weeks of follow-up.	37.5% 3/8 • 28 days of treatment and 2 weeks of follow-up.	36.4% 4/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	33.3% 3/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	18.2% 2/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Diarrhea	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Nausea	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Abdominal pain upper	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Gastritis	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Mouth ulceration	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Toothache	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Vomiting	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
General disorders Fatigue	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	22.2% 2/9 • 28 days of treatment and 2 weeks of follow-up.
General disorders Vessel puncture site pain	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	22.2% 2/9 • 28 days of treatment and 2 weeks of follow-up.
General disorders Non-cardiac chest pain	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	22.2% 2/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Chills	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Pain	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Gastrointestinal disorders Puncture site pain	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
General disorders Swelling face	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Hepatobiliary disorders Cholelithiasis	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Hepatobiliary disorders Portal fibrosis	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Bacterial infection	28.6% 2/7 • 28 days of treatment and 2 weeks of follow-up.	25.0% 2/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Influenza	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Malaria	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Urinary tract infection	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Body tinea	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Fungal skin infection	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Lip infection	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Nasopharyngitis	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Respiratory tract infection	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Rhinitis	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Septic rash	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Tinea versicolour	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Infections and infestations Vulvovaginal candidiasis	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations White blood cell count increased	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	22.2% 2/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Neutrophil count increased	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Urine leukocyte esterase positive	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Alanine aminotransferase increased	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Blood alkaline phosphatase increased	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Blood creatine phosphokinase increased	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Blood lactate dehydrogenase increased	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Urine blood present	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations C-reactive protein increased	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	25.0% 2/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations High density lipoprotein decreased	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Lymphocyte count increased	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Nitrite urine present	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Platelet count decreased	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Platelet count increased	28.6% 2/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Investigations Streptococcus test positive	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Musculoskeletal and connective tissue disorders Arthralgia	42.9% 3/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	33.3% 3/9 • 28 days of treatment and 2 weeks of follow-up.	33.3% 3/9 • 28 days of treatment and 2 weeks of follow-up.
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	22.2% 2/9 • 28 days of treatment and 2 weeks of follow-up.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	36.4% 4/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	11.1% 1/9 • 28 days of treatment and 2 weeks of follow-up.
Musculoskeletal and connective tissue disorders Flank pain	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Nervous system disorders Headache	57.1% 4/7 • 28 days of treatment and 2 weeks of follow-up.	50.0% 4/8 • 28 days of treatment and 2 weeks of follow-up.	27.3% 3/11 • 28 days of treatment and 2 weeks of follow-up.	33.3% 3/9 • 28 days of treatment and 2 weeks of follow-up.	22.2% 2/9 • 28 days of treatment and 2 weeks of follow-up.
Nervous system disorders Dizziness	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Nervous system disorders Syncope	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Renal and urinary disorders Urine abnormality	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Reproductive system and breast disorders Vulvovaginal rash	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 1/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	12.5% 1/8 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/7 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/8 • 28 days of treatment and 2 weeks of follow-up.	9.1% 1/11 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.	0.00% 0/9 • 28 days of treatment and 2 weeks of follow-up.

Additional Information

Varsha Bhatt

Bausch Health Americas, Inc

Phone: 7072301712

Email: varsha.bhatt@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Please contact sponsor for details.
• Publication restrictions are in place

Restriction type: OTHER