Triple Therapy With Tegoprazan in H. Pylori Positive Patients

• ClinicalTrials.gov Identifier: NCT03498456
• Recruitment Status: Completed
• First Posted: April 13, 2018
• Last Update Posted: May 8, 2020
• Sponsor: HK inno.N Corporation
• Information provided by (Responsible Party): HK inno.N Corporation

Tracking Information

• First Submitted Date: April 8, 2018
• First Posted Date: April 13, 2018
• Last Update Posted Date: May 8, 2020
• Actual Study Start Date: June 28, 2018
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Triple Therapy With Tegoprazan in H. Pylori Positive Patients
• 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
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Helicobacter Pylori Infection

Intervention

• 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)
• 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)

Study Arms

• Experimental: Tegoprazan/Amoxicillin/Clarithromycin
  Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
  Intervention: Drug: Tegoprazan/Amoxicillin/Clarithromycin
• Active Comparator: Lansoprazole/Amoxicillin/Clarithromycin
  Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
  Intervention: Drug: Lansoprazole/Amoxicillin/Clarithromycin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2018): 284
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 31, 2019
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03498456
• Other Study ID Numbers: CJ_APA_307
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: HK inno.N Corporation
• Study Sponsor: HK inno.N Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hwoon Yong Jung, Professor; Asan Medical Center

• PRS Account: HK inno.N Corporation
• Verification Date: May 2020