NCT02711176

Brief Summary

This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

February 9, 2016

Last Update Submit

June 7, 2017

Conditions

Helicobacter Infection

Outcome Measures

Primary Outcomes (1)

  • The rate of H.pylori eradication

    Breath Urea Test

    42 days after study completion

Secondary Outcomes (1)

  • Drug Compliance

    within the first week after study completion

Study Arms (2)

Tavanex & Nexium & Tinafas

EXPERIMENTAL

Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"

Drug: NexiumDrug: TinafasDrug: Tavanex

Lanzol & Klacid &Iramox

ACTIVE COMPARATOR

Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days

Drug: LanzolDrug: KlacidDrug: Iramox

Interventions

NexiumDRUG

Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily

Also known as: Esomeprazole
Tavanex & Nexium & Tinafas
TinafasDRUG

Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily

Also known as: Tinidazole
Tavanex & Nexium & Tinafas
TavanexDRUG

Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily

Also known as: Levofluxacine
Tavanex & Nexium & Tinafas
LanzolDRUG

Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily

Also known as: lansoprazole
Lanzol & Klacid &Iramox
KlacidDRUG

Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily

Also known as: clarithromycin
Lanzol & Klacid &Iramox
IramoxDRUG

Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily

Also known as: amoxicillin
Lanzol & Klacid &Iramox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who proved H. pylori infection following three methods
  • Positive rapid urease test
  • Histologic evidence of H. pylori by modified Giemsa staining
  • Positive stool Antigen Test

You may not qualify if:

  • Patients who received eradication therapy for H. pylori infection, previously
  • H. pylori eradication failure because of poor compliance
  • The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
  • Advanced gastric cancer or other malignancy
  • Abnormal liver function or liver cirrhosis
  • Abnormal renal function or chronic kidney disease
  • Other severe concurrent diseases
  • Previous allergic reactions to the study drugs
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilam University of Medical Scienvc

Īlām, 6939177143, Iran

Location

Related Publications (1)

  • Shahbazi S, Vahdat Shariatpanahi Z. Comparison between daily single-dose triple therapy and conventional triple therapy on patient compliance and Helicobacter pylori eradication: A randomized controlled trial. Indian J Gastroenterol. 2018 Nov;37(6):550-554. doi: 10.1007/s12664-018-0916-z. Epub 2019 Jan 12.

    PMID: 30635887DERIVED

MeSH Terms

Conditions

Helicobacter Infections

Interventions

EsomeprazoleTinidazoleLansoprazoleClarithromycinAmoxicillin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNitroimidazolesNitro CompoundsImidazolesAzolesErythromycinMacrolidesPolyketidesLactonesAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmides

Study Officials

  • Shaahin Shahbazi, MD

    Assistant Professor, Ilam University of Medical Sciences,Head of Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 9, 2016

First Posted

March 17, 2016

Study Start

September 1, 2016

Primary Completion

March 27, 2017

Study Completion

March 27, 2017

Last Updated

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)