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

NCT05933031
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Phase
Phase 2
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Recruitment status
Unknown
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Participants
381
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Lead sponsor
HK inno.N Corporation
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Start date
2023-02-27
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Number of sites
1
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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.
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Short title
Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 2
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Study type
Interventional
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Completion date
2024-12-31
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First posted
2023-07-06
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Registry last updated
2023-07-06
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Primary completion date
2024-12-31
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Start date
2023-02-27
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Participants
381
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Participant count basis
Estimated
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Planned participants
381
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
HK inno.N Corporation
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05933031
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ClinicalTrials.gov ID
NCT05933031
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. H. pylori eradication rate

    Timeframe: 42 days

    Assess H. pylori eradication rate by UBT

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
19 Years
Maximum age
75 Years
Healthy volunteers
No

  • H. pylori positive at screening
  • Subjects who have upper gastrointestinal disease

  • 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
Sources for eligibility
clinicaltrials.gov

  • Chung-Ang University HosptialSeoul, South KoreaRecruiting
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)