Helicobacter Pylori Eradication With a New Sequential Tre... | NCT00132171

Studies
Helicobacter Pylori Eradication With a New Sequential Treatment

NCT00132171

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Completed

Last Update Posted

Mar 18, 2021Actual

Enrollment

1,000

Phase

Phase 3

Conditions

Helicobacter Pylori Infection
Non Ulcer Dyspepsia
Duodenal Ulcer
Gastric Ulcer
Chronic Active Gastritis
Gastritis

Interventions

Sequential therapy

Countries

Italy

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

Mar 2021

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

Jan 2001

Primary Completion Date

Not provided

Completion Date

Dec 2001

First Submitted Date

Aug 18, 2005

First Submission Date that Met QC Criteria

Aug 18, 2005

First Posted Date

Aug 19, 2005Estimated

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

Mar 17, 2021

Last Update Posted Date

Mar 18, 2021Actual

Description Module

Brief Summary

Eradication rates of Helicobacter pylori (H. pylori) with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. The study aimed to assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection.

Detailed Description

One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy [rabeprazole (20 mg twice daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg, all twice daily for the remaining 5 days] or standard 7-day therapy [corrected] [rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g), all twice daily]. H. pylori status was assessed by histology, rapid urease test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000

Name	Type	Description	Arm Group Labels	Other Names
Sequential therapy	Drug

Measure	Description	Time Frame
Helicobacter pylori eradication rate

Measure	Description	Time Frame
Compliance to therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of active H. pylori infection
Age >18 years

Exclusion Criteria:

Allergy to drug administered
Liver or kidney failure
Pregnancy
Previous treatment for H. pylori infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angelo Zullo, MD	Nuovo Regina Margherita Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology - Nuovo Regina Margherita Hospital		Rome		00153	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12641522	Result	Zullo A, Vaira D, Vakil N, Hassan C, Gatta L, Ricci C, De Francesco V, Menegatti M, Tampieri A, Perna F, Rinaldi V, Perri F, Papadia C, Fornari F, Pilati S, Mete LS, Merla A, Poti R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, Morini S. High eradication rates of Helicobacter pylori with a new sequential treatment. Aliment Pharmacol Ther. 2003 Mar 1;17(5):719-26. doi: 10.1046/j.1365-2036.2003.01461.x.

ID	Term
D004381	Duodenal Ulcer
D013276	Stomach Ulcer
D005756	Gastritis

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases