Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

NCT ID: NCT03087162

Last Updated: 2018-04-03

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

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-12-01

Brief Summary

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New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.

Detailed Description

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Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.

Conditions

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H Pylori Eradication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Once daily dose dexlansoprazole

Group 1 Dexlansoprazole 60 mg by oral once daily for 14 days (Levofloxacin 500 mg by oral once daily for 14 days Amoxicillin 1000 mg by oral bid for 14 days Bismuth 1048 mg by oral bid for 14 days)

Group Type EXPERIMENTAL

Dexlansoprazole 60 mg once daily

Intervention Type DRUG

Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm

Twice daily dose dexlansoprazole

Group 2 Dexlansoprazole 60 mg oral bid 14 Days (Levofloxacin 500 mg od oral 14 Days Amoxicillin 1000 mg bid oral 14 Days Bismuth 1048 mg bid oral 14 Days)

Group Type ACTIVE_COMPARATOR

Dexlansoprazole 60 mg once daily

Intervention Type DRUG

Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm

Interventions

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Dexlansoprazole 60 mg once daily

Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm

Intervention Type DRUG

Other Intervention Names

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dexilant

Eligibility Criteria

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Inclusion Criteria

1. Age 18-75 year-patient
2. Diagnosed as positive Helicobacter Pylori testing by any of the following methods:

* Rapid urease test or Histology
3. Inform consent

Exclusion Criteria

1. Previous history of Helicobacter pylori eradication
2. Contraindications or allergic reactions to the study drugs
3. Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases
4. Decompensated Liver cirrhosis or chronic kidney disease (GFR\< 30)
5. Mental disorders or alcohol or drug addiction
6. Pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Parin siriwat

Fellowship of Gastroenterology Unit, Ramathibodi Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akrawit Pulsombat, Doctor

Role: STUDY_DIRECTOR

Ramathibodi Hospital

Locations

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Parin siriwat

Bangkok, , Thailand

Site Status

Countries

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Thailand

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Psiriwat

Identifier Type: -

Identifier Source: org_study_id

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