Comparison of Daily Single Dose Triple and Conventional T... | NCT02711176

Studies
Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection

NCT02711176

Sponsor

Zahra Vahdat Shariatpanahi

Status

Completed

Last Update Posted

Jun 8, 2017Actual

Enrollment

212Actual

Phase

Phase 4

Conditions

Helicobacter Infection

Interventions

Nexium
Tinafas
Tavanex
Lanzol
Klacid
Iramox

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Mar 27, 2017Actual

Completion Date

Mar 27, 2017Actual

First Submitted Date

Feb 9, 2016

First Submission Date that Met QC Criteria

Mar 12, 2016

First Posted Date

Mar 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2017

Last Update Posted Date

Jun 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zahra Vahdat Shariatpanahi, Assistant Professor, Ilam University of Medical SciencesSponsor-Investigator

Lead Sponsor

Zahra Vahdat ShariatpanahiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined.

The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

212Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Nexium Drug: Tinafas Drug: 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: Lanzol Drug: Klacid Drug: Iramox

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nexium	Drug	Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily	Tavanex & Nexium & Tinafas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of H.pylori eradication	Breath Urea Test	42 days after study completion

Secondary Outcomes

Measure	Description	Time Frame
Drug Compliance	Interview	within the first week after study completion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaahin Shahbazi, MD	Assistant Professor, Ilam University of Medical Sciences,Head of Faculty of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ilam University of Medical Scienvc		Īlām		6939177143	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30635887	Derived	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.

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D064098	Esomeprazole
D014011	Tinidazole
D064747	Lansoprazole
D017291	Clarithromycin
D000658	Amoxicillin

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds