Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

NCT03087162 | Completed Phase 4 DMC

• 1 other identifier: Psiriwat
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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 daily DRUG

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 dexlansoprazole; Twice daily dose dexlansoprazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:
• Rapid urease test or Histology
• Inform consent

You may not qualify if:

• Previous history of Helicobacter pylori eradication
• Contraindications or allergic reactions to the study drugs
• Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases
• Decompensated Liver cirrhosis or chronic kidney disease (GFR\< 30)
• Mental disorders or alcohol or drug addiction
• Pregnancy or lactation

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Parin siriwat

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Dexlansoprazole

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Akrawit Pulsombat, Doctor

  Ramathibodi Hospital

  STUDY DIRECTOR

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
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 3, 2018

Record last verified: 2018-04

Locations

TH (1)