Trial Outcomes & Findings for Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants (NCT NCT06076694)

NCT ID: NCT06076694

Last Updated: 2023-12-12

Results Overview

Eradication rate of H. pylori is defined as negative urea breath test result.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Group A, B,C,control group: Urea breath test is assessed Day 44~Day 50 after the first dose; Group D: Urea breath test is assessed Day 37~ Day 43 after the first dose

Results posted on

2023-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Group A TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days	Group B TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days	Group C TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days	Group D TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days	Control Group Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days
Overall Study STARTED	20	20	10	10	20
Overall Study COMPLETED	19	18	10	10	20
Overall Study NOT COMPLETED	1	2	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=20 Participants TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days	Group B n=20 Participants TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days	Group C n=10 Participants TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days	Group D n=10 Participants TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days	Control Group n=20 Participants Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	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
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	20 Participants n=21 Participants	80 Participants n=8 Participants
Age, Categorical >=65 years	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
Age, Continuous	40.2 years STANDARD_DEVIATION 9.84 • n=5 Participants	38.1 years STANDARD_DEVIATION 8.65 • n=7 Participants	35.8 years STANDARD_DEVIATION 9.08 • n=5 Participants	40.6 years STANDARD_DEVIATION 7.03 • n=4 Participants	37.6 years STANDARD_DEVIATION 10.62 • n=21 Participants	38.5 years STANDARD_DEVIATION 9.27 • n=8 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	40 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants	40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	20 Participants n=21 Participants	80 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	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) White	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) 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	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

PRIMARY outcome

Timeframe: Group A, B,C,control group: Urea breath test is assessed Day 44~Day 50 after the first dose; Group D: Urea breath test is assessed Day 37~ Day 43 after the first dose

Population: Modified Intent-to-Treat Analysis Set (mITT): Refers to all randomized participants who have 14C UBT performed on Day 28 to 34 after the last dose of the study.

Eradication rate of H. pylori is defined as negative urea breath test result.