Trials Sponsors Conditions Drugs Pricing

Conditions

H Pylori Eradication

Outcome Measures

Primary Outcomes (1)

Eradication rate (percentage)
Compare eradication rate of helicobacter pylori between 2 groups
Jan17-Nov17, Total 11 months

Secondary Outcomes (2)

To compare drug compliance
jan17-Nov17, Total 11 months
To compare drug adverse event
jan17-Nov17, Total 11 months

Study Arms (2)

Once daily dose dexlansoprazole

EXPERIMENTAL

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)

Drug: Dexlansoprazole 60 mg once daily

Twice daily dose dexlansoprazole

ACTIVE COMPARATOR

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)

Drug: Dexlansoprazole 60 mg once daily

Interventions

Dexlansoprazole 60 mg once dailyDrug

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

Also known as: dexilant

Once daily dose dexlansoprazoleTwice daily dose dexlansoprazole

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Ramathibodi Hospital
Otherlead

Study Sites (1)

Parin siriwat

Bangkok, 10400, Thailand

MeSH Terms

Interventions

Dexlansoprazole

Intervention Hierarchy (Ancestors)

Lansoprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Akrawit Pulsombat, Doctor
Ramathibodi Hospital
STUDY DIRECTOR

Enrollment

180 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Fellowship of Gastroenterology Unit, Ramathibodi Hospital

Study Record Dates

First Submitted

February 9, 2017

First Posted

March 22, 2017

Study Start

January 1, 2017

Actual (reported)

Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Once daily dose dexlansoprazole

Twice daily dose dexlansoprazole

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Once daily dose dexlansoprazole

Twice daily dose dexlansoprazole

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations