NCT00132171

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2001

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

January 1, 2001

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

First QC Date

August 18, 2005

Last Update Submit

March 17, 2021

Conditions

Helicobacter Pylori InfectionNon Ulcer DyspepsiaDuodenal UlcerGastric UlcerChronic Active GastritisGastritis

Keywords

Helicobacter pyloriEradicationSequential therapyStandard therapy

Outcome Measures

Primary Outcomes (1)

  • Helicobacter pylori eradication rate

Secondary Outcomes (1)

  • Compliance to therapy

Interventions

Sequential therapyDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of active H. pylori infection
  • Age \>18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology - Nuovo Regina Margherita Hospital

Rome, 00153, Italy

Location

Related Publications (1)

  • 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.

    PMID: 12641522RESULT

MeSH Terms

Conditions

Duodenal UlcerStomach UlcerGastritis

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastroenteritis

Study Officials

  • Angelo Zullo, MD

    Nuovo Regina Margherita Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 19, 2005

Study Start

January 1, 2001

Study Completion

December 1, 2001

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

IT(1)