Ignite Creation Date:
2025-12-18 @ 8:10 AM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT07122024
Status:
None
Last Update Posted:
2025-08-14 00:00:00
First Post:
2025-06-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
Sponsor:
None
Organization:
Study Overview
Official Title:
Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
Status:
None
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1. Study duration: Starting from the date of ethics approval and clinical registration completion, the project will last for 1 year. If you agree to participate in this study, you will be assigned to one of the three treatment groups through randomization (with a 33% probability for each group), with 138 subjects in each group.
The study is divided into a screening phase and a treatment phase, with a total of 4 visit points:
Screening period: -7 to 0 days
1. Obtain informed consent;
2. Collect demographic information and baseline characteristics of the subject;
3. Record medical history and current treatment, concomitant medications (including prescription and over-the-counter drugs);
4. Vital signs, physical examination;
5. H. pylori test;
6. Review inclusion and exclusion criteria;
7. Eligible subjects will be randomized to receive assigned treatment based on randomization numbers.
Visit period V2 (telephone visit):
K10 group: 10 days (±3 days), K14 group: 14 days (±3 days), R14 group: 14 days (±3 days)
1. Vital signs, physical examination;
2. Record concomitant medications;
3. Record adverse events after medication. Visit period V3: 9 weeks (±7 days)
1\) Vital signs, physical examination; 2) H. pylori test; 3) Record concomitant medications; 4) Record adverse events after medication.
The study is divided into a screening phase and a treatment phase, with a total of 4 visit points:
Screening period: -7 to 0 days
1. Obtain informed consent;
2. Collect demographic information and baseline characteristics of the subject;
3. Record medical history and current treatment, concomitant medications (including prescription and over-the-counter drugs);
4. Vital signs, physical examination;
5. H. pylori test;
6. Review inclusion and exclusion criteria;
7. Eligible subjects will be randomized to receive assigned treatment based on randomization numbers.
Visit period V2 (telephone visit):
K10 group: 10 days (±3 days), K14 group: 14 days (±3 days), R14 group: 14 days (±3 days)
1. Vital signs, physical examination;
2. Record concomitant medications;
3. Record adverse events after medication. Visit period V3: 9 weeks (±7 days)
1\) Vital signs, physical examination; 2) H. pylori test; 3) Record concomitant medications; 4) Record adverse events after medication.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: