Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

NCT ID: NCT04432233

Last Updated: 2020-08-27

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-06-15

Brief Summary

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Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.

Detailed Description

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Conditions

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Helicobacter Pylori Infection Intravenous Drug Usage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous therapy

Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks.

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Proton pump inhibitor

Metronidazole

Intervention Type DRUG

antibiotic for H. pylori eradication

Levofloxacin

Intervention Type DRUG

antibiotic for H. pylori eradication

Interventions

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Esomeprazole

Proton pump inhibitor

Intervention Type DRUG

Metronidazole

antibiotic for H. pylori eradication

Intervention Type DRUG

Levofloxacin

antibiotic for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged between 18 and 75 years old
* Without previous Helicobacter pylori treatment
* Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination
* Ability and willingness to participate in the study and to sign and give informed consent
* Positive for Helicobacter pylori IgM antibody

Exclusion Criteria

* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Decline to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Lu, PHD,MD

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiao Liang, PHD,MD

Role: CONTACT

13120839615

Facility Contacts

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Xiao Liang, PHD,MD

Role: primary

13120839615

Other Identifiers

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rjkls2020031

Identifier Type: -

Identifier Source: org_study_id

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