Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triple Therapy With Tegoprazan in H. Pylori Positive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03498456
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Brief Summary:
The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Tegoprazan/Amoxicillin/Clarithromycin Drug: Lansoprazole/Amoxicillin/Clarithromycin Phase 3

Detailed Description:
This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : February 6, 2020
Estimated Study Completion Date : February 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tegoprazan/Amoxicillin/Clarithromycin
Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
Drug: Tegoprazan/Amoxicillin/Clarithromycin
Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
Other Name: Tegoprazan triple therapy (TAC)

Active Comparator: Lansoprazole/Amoxicillin/Clarithromycin
Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
Drug: Lansoprazole/Amoxicillin/Clarithromycin
Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
Other Name: Lansoprazole triple therapy (LAC)




Primary Outcome Measures :
  1. H. pylori eradication rate [ Time Frame: 6 weeks ]
    Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • H. pylori positive based on the screening test
  • Peptic ulcer disease

Exclusion Criteria:

  • Prior treatment for H. pylori eradication
  • Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
  • Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498456


Contacts
Layout table for location contacts
Contact: Ah Rong Kim 82-2-6740-2441 ahrong.kim@cj.net
Contact: Eun Ji Kim 82-2-6740-2443 eunji.kim@cj.net

Locations
Layout table for location information
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
Layout table for investigator information
Principal Investigator: Hwoon Yong Jung, Professor Asan Medical Center

Layout table for additonal information
Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT03498456     History of Changes
Other Study ID Numbers: CJ_APA_307
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Clarithromycin
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Lansoprazole
Dexlansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors