A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication

NCT03716622 | Completed Phase 4 DMC

• 1 other identifier: 2018SDU-QILU-G112
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to assess and compare the effectiveness of clarithromycin- and furazolidone-based regimens as primary therapies in eradicating H. pylori.

Conditions

Helicobacter Pylori

Keywords

Helicobacter Pylori; furazolidone; clarithromycin; bismuth-containing quadruple regimen

Outcome Measures

Primary Outcomes (1)

• the eradication rate of the two groups

  26 months

Study Arms (2)

bismuth-clarithromycin-containing group

ACTIVE COMPARATOR

Patients in bismuth-clarithromycin-containing group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 500mg po bid for 14d

Drug: Clarithromycin

bismuth-furazolidone-containing quadruple group

EXPERIMENTAL

patients in bismuth-furazolidone-containing quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 240mg po bid, and furazolidone (Liteling) 100mg po bid for 14d

Drug: Furazolidone

Interventions

Furazolidone DRUG

bismuth-furazolidone-containing quadruple regimens

bismuth-furazolidone-containing quadruple group

Clarithromycin DRUG

bismuth-clarithromycin-containing quadruple regimens

bismuth-clarithromycin-containing group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, aged between 18 and 75years old, 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

Furazolidone; Clarithromycin

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Furans; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 23, 2018
• Study Start: July 31, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

CN (1)