Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

May 18, 2023

Primary Completion Date

December 24, 2023

Study Completion Date

March 26, 2024

Conditions
H.Pylori Infection
Interventions
DRUG

Rifasutenizol capsules

400 mg, BID, taken orally within half an hour after breakfast and dinner.

DRUG

Rabeprazole sodium enteric-coated tablets

20 mg, BID, taken orally within half an hour before breakfast and dinner.

DRUG

Amoxicillin Capsules

1 g, BID, taken orally within half an hour after breakfast and dinner.

DRUG

Clarithromycin placebo tablets

BID, taken orally within half an hour after breakfast and dinner.

DRUG

Bismuth potassium citrate placebo capsules

BID, taken orally within half an hour before breakfast and dinner.

DRUG

Clarithromycin tablets

500 mg, BID, taken orally within half an hour after breakfast and dinner.

DRUG

Bismuth potassium citrate capsules

240 mg, BID, taken orally within half an hour before breakfast and dinner.

DRUG

Rifasutenizol placebo capsules

BID, taken orally within half an hour before breakfast and dinner.

Trial Locations (1)

Unknown

Peking University Third Hospital, Beijing

All Listed Sponsors
lead

TenNor Therapeutics (Suzhou) Limited

INDUSTRY

NCT05857163 - Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection | Biotech Hunter | Biotech Hunter