Overview

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

Status:
Recruiting
Trial end date:
2021-12-08
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Treatments:
Amoxicillin
Bismuth
Citric Acid
Clarithromycin
Esomeprazole
Potassium Citrate
Sodium Citrate
Criteria
Inclusion Criteria:

1. Helicobacter pylori (HP)-positive participants as determined by ^13C-urea breath test
(^13C-UBT) at the start of the study (Visit 1 [screening]) and who require HP eradication
in Physician judgment.

Exclusion Criteria:

1. Participant had any of the following conditions at the start of the study (Visit 1,
screening): acute upper gastrointestinal bleeding, active gastric ulcer (GU) or
duodenal ulcer (DU) characterized by defective mucos with white coating (with or
without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion
(AGML), or acute duodenal mucosal lesion (ADML). However, participants with gastritis,
gastric or duodenal erosion are permitted to participate.

2. Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those
with a history of gastric acid hypersecretion.

3. Participant has a history of malignancy or was treated for malignancy within 5 years
before the start of the screening visit (the participant may be included in the study
if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).

4. Participant has a known acquired immunodeficiency syndrome or hepatitis infection,
including hepatitis virus carriers (hepatitis B surface antigen [HBsAg] or hepatitis C
virus [HCV]- antibody-positive).