Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

NCT ID: NCT02732249

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Triple regimen group

Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Given 30 min before morning and evening meals

Clarithromycin

Intervention Type DRUG

Given 30 min after morning and evening meals

Metronidazole

Intervention Type DRUG

Given 30 min after meals or at bedtime

Low metronidazole group

Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Given 30 min before morning and evening meals

Bismuth Potassium Citrate

Intervention Type DRUG

Given 30 min before morning and evening meals

Clarithromycin

Intervention Type DRUG

Given 30 min after morning and evening meals

Metronidazole

Intervention Type DRUG

Given 30 min after meals or at bedtime

High metronidazole group

Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Given 30 min before morning and evening meals

Bismuth Potassium Citrate

Intervention Type DRUG

Given 30 min before morning and evening meals

Clarithromycin

Intervention Type DRUG

Given 30 min after morning and evening meals

Metronidazole

Intervention Type DRUG

Given 30 min after meals or at bedtime

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Esomeprazole

Given 30 min before morning and evening meals

Intervention Type DRUG

Bismuth Potassium Citrate

Given 30 min before morning and evening meals

Intervention Type DRUG

Clarithromycin

Given 30 min after morning and evening meals

Intervention Type DRUG

Metronidazole

Given 30 min after meals or at bedtime

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection

Exclusion Criteria

* Previous H. pylori eradication therapy
* Less than 18 years old
* With history of H. pylori infection treatment
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hong lu, MD

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

rjkls2016068

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.