Trial Outcomes & Findings for A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules (NCT NCT06076681)
NCT ID: NCT06076681
Last Updated: 2023-11-22
Results Overview
Eradication rate of H. pylori is defined as negative urea breath test result.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)
Results posted on
2023-11-22
Participant Flow
Participant milestones
| Measure |
Group A
TNP-2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(200mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group B
TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group C
TNP-2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(600 mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group D
TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg), rabeprazole sodium enteric-coated tablets(20mg) and Amoxicillin capsules(1g) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
Baseline characteristics by cohort
| Measure |
Group A
n=10 Participants
TNP-2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(200mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group B
n=10 Participants
TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group C
n=10 Participants
TNP-2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(600 mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group D
n=10 Participants
TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg), rabeprazole sodium enteric-coated tablets(20mg) and Amoxicillin capsules(1g) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Total
n=40 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
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 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
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 10.31 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 6.36 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 10.73 • n=4 Participants
|
40.0 years
STANDARD_DEVIATION 8.99 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)Eradication rate of H. pylori is defined as negative urea breath test result.
Outcome measures
| Measure |
Group A
n=10 Participants
TNP-2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(200mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group B
n=10 Participants
TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group C
n=10 Participants
TNP-2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(600 mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group D
n=10 Participants
TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg), rabeprazole sodium enteric-coated tablets(20mg) and Amoxicillin capsules(1g) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
|---|---|---|---|---|
|
The Eradication Rate of Helicobacter Pylori Infection
|
0 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=10 participants at risk
TNP-2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(200mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group B
n=10 participants at risk
TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group C
n=10 participants at risk
TNP-2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(600 mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
Group D
n=10 participants at risk
TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg), rabeprazole sodium enteric-coated tablets(20mg) and Amoxicillin capsules(1g) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.
|
|---|---|---|---|---|
|
Investigations
Blood Creatinine Increased
|
30.0%
3/10 • Number of events 4 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 2 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 2 • Day 1 to Day 17
|
|
Investigations
Alanine aminotransferase(AST)increased
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
20.0%
2/10 • Number of events 2 • Day 1 to Day 17
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
2/10 • Number of events 3 • Day 1 to Day 17
|
20.0%
2/10 • Number of events 2 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
1/10 • Number of events 2 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
20.0%
2/10 • Number of events 2 • Day 1 to Day 17
|
|
Investigations
White blood cell count decreased
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
20.0%
2/10 • Number of events 2 • Day 1 to Day 17
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Day 1 to Day 17
|
20.0%
2/10 • Number of events 2 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
10.0%
1/10 • Number of events 1 • Day 1 to Day 17
|
0.00%
0/10 • Day 1 to Day 17
|
Additional Information
TenNor Medical Information
TenNor Therapeutics (Suzhou) Limited.
Phone: 0512-86861979
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place