Clincosm LogoSign in Get a demo

Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05933031
Collaborator
(none)
381
Enrollment
1
Location
3
Arms
22.1
Anticipated Duration (Months)
17.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tegoprazan 50 mg Triple Therapy
  • Drug: Tegoprazan 100 mg Triple Therapy
  • Drug: Lansoprazole Triple Therapy
 Phase 2

Detailed Description

A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 days.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
381 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients
Actual Study Start Date :
Feb 27, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tegoprazan 50 mg

Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Drug: Tegoprazan 50 mg Triple Therapy
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Experimental: Tegoprazan 100 mg

Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Drug: Tegoprazan 100 mg Triple Therapy
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Active Comparator: Lansoprazole

Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days

Drug: Lansoprazole Triple Therapy
Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days

Outcome Measures

Primary Outcome Measures

  1. H. pylori eradication rate [42 days]

    Assess H. pylori eradication rate by UBT

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. pylori positive at screening

  • Subjects who have upper gastrointestinal disease

Exclusion Criteria:

  • Having received prior therapy for eradication of H. pylori

  • Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days

  • Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chung-Ang University Hosptial Seoul Korea, Republic of

Sponsors and Collaborators

  • HK inno.N Corporation

Investigators

  • Principal Investigator: Jae Gyu Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HK inno.N Corporation
ClinicalTrials.gov Identifier:
NCT05933031
Other Study ID Numbers:
  • IN_APA_E02
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lansoprazole
Dexlansoprazole

Study Results

No Results Posted as of Jul 6, 2023