Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

• Sponsor: Incheon St.Mary's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04674774
• Collaborator: (none)
• Enrollment: 217
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 16.8

Study Details

Study Description

Brief Summary

This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Tegoprazan; Drug: Lansoprazole	N/A

Detailed Description

This is a multi-center, double-blind, randomized, active-controlled study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study
• Actual Study Start Date: Mar 4, 2021
• Anticipated Primary Completion Date: Feb 28, 2022
• Anticipated Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tegoprazan based bismuth quadruple therapy group tegoprazan based bismuth quadruple therapy group	Drug: Tegoprazan; oral administration of tegoprazan-based bismuth quadruple therapy(tegoprazan 50 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 days
Active Comparator: PPI based bismuth quadruple therapy group PPI based bismuth quadruple therapy group	Drug: Lansoprazole; oral administration of PPI-based bismuth quadruple therapy(lansoprazole 30 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 day

Outcome Measures

Primary Outcome Measures

1. H. pylori eradication rate of each group [UBT test 4 weeks after completion of eradication treatment]

   H. pylori eradication rate of each group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection

Exclusion Criteria:

1. patients who have H.pylori eradication history

2. patients with history of gastric cancer surgery

3. patients who have taken antibiotics within 4 weeks prior to trial

4. a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine

5. pregnant or breastfeeding women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Incheon St. Mary's Hospital	Incheon		Korea, Republic of

Sponsors and Collaborators

• Incheon St.Mary's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joon Sung Kim, Assistant Professor, Incheon St.Mary's Hospital
• ClinicalTrials.gov Identifier: NCT04674774
• Other Study ID Numbers: OC20MIDI0057
• First Posted: Dec 19, 2020
• Last Update Posted: Feb 10, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Helicobacter Infections; Lansoprazole; Dexlansoprazole

Study Results

No Results Posted as of Feb 10, 2022