A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients

NCT04101708 | Unknown Phase 4 DMC

• 1 other identifier: 2019SDU-QILU-G099
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess and compare the effectiveness and safety of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients for eradicating H.pylori.

Conditions

Helicobacter Pylori

Keywords

elderly,helicobacter pylori eradication,dual therapy,half-dose clarithromycin

Outcome Measures

Primary Outcomes (1)

• eradication rate of the two groups

  24 months

Study Arms (2)

high dose dual group

EXPERIMENTAL

Patients in high dose dual group will receive lansoprazole (Takepron) 30mg po qid, amoxicillin 750mg po qid for 14d

Drug: Lansoprazole, Amoxicillin

half-dose clarithromycin-containing bismuth quadruple group

ACTIVE COMPARATOR

Patients in half-dose clarithromycin-containing bismuth quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 250mg po bid for 14d

Drug: Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate

Interventions

Lansoprazole, Amoxicillin DRUG

high dose dual regimen

high dose dual group

Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate DRUG

half-dose clarithromycin-containing bismuth quadruple regimen

half-dose clarithromycin-containing bismuth quadruple group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients, aged greater than 65 , with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

You may not qualify if:

• Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 257000, China

Location

MeSH Terms

Interventions

Lansoprazole; Amoxicillin; Clarithromycin; bismuth tripotassium dicitrate

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

15588818685; zuoxiuli@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 24, 2019
• Study Start: September 20, 2019
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2022
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

CN (1)