Eradication of H. Pylori Infection With Moxifloxacin

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-06-08

Brief Summary

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The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.

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Detailed Description

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Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.

Conditions

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Helicobacter Pylori Infection Helicobacter Pylori Infection, Susceptibility to

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomized into two regimens:

1. Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or
2. Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levofloxacin-based sequential Therapy

1. Tablets Levofloxacin 500mg BID for the first five days
2. Tablet Amoxicillin 1 gm BID for first five days
3. Capsules Omeprazole 20 mg BID for first five days followed by

1\. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days

Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms

Group Type ACTIVE_COMPARATOR

Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID

Intervention Type DRUG

The eradication rate of H. Pylori with levofloxacin-based sequential therapy

Moxifloxacin-based Triple Therapy

1. Tablet Moxifloxacin 400 mg OD for ten days
2. Tablet Amoxicillin 1 gm BID for ten days
3. Capsule Omeprazole 20 mg BID for ten days

Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance.

Group Type ACTIVE_COMPARATOR

Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID

Intervention Type DRUG

The eradication rate of H. Pylori with moxifloxacin-based triple therapy

Interventions

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Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID

The eradication rate of H. Pylori with levofloxacin-based sequential therapy

Intervention Type DRUG

Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID

The eradication rate of H. Pylori with moxifloxacin-based triple therapy

Intervention Type DRUG

Other Intervention Names

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Levofloxacin Amoxicillin Omeprazole Tinidazole Moxifloxacin Amoxicillin Omeprazole

Eligibility Criteria

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Inclusion Criteria

1. Successful isolation of H. pylori from the patient, and
2. patients of at least 18 years of age.

Exclusion Criteria

1. age under 18 years
2. presence of clinically signiﬁcant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases),
3. previous gastric surgery,
4. allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No