NCT00403364

Brief Summary

To assess if a sequential treatment regimen better eradicates H. pylori than does a triple drug regimen in adults with dyspepsia or peptic ulcer disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2003

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

July 1, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

First QC Date

November 22, 2006

Last Update Submit

March 17, 2021

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infectionTreatmentDouble blind placebo controlled trial

Outcome Measures

Primary Outcomes (1)

  • 13C urea breath test, upper endoscopy, histology, rapid urease test assessment

Secondary Outcomes (1)

  • bacterial culture, and antibiotic resistance assessment

Interventions

Placebo amoxicillin pantoprazole clarithromycin tinidazoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Helicobacter pylori infected patients \> 18 years

You may not qualify if:

  • previous H. pylori eradication treatment;
  • Use of proton pump inhibitors, H2-receptor antagonists, bismuth preparations and antibiotics in the previous 4 weeks;
  • Concomitant anticoagulant or ketoconazole use, due to the potential of interaction with the study medications;
  • Zollinger-Ellison syndrome;
  • Previous surgery of the esophagus and/or upper gastrointestinal tract (with the exception of appendectomy, polypectomy and cholecystectomy);
  • Severe or unstable cardiovascular, pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematological disorder; any other clinically significant medical condition that could increase the risk to the study participants; malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer or Barrett esophagus with high grade dysplasia;
  • Drug or medication abuse within the past year;
  • Severe psychiatric or neurological disorders;
  • Pregnant or nursing women sexually active women of child bearing potential who were not willing to practice medically acceptable contraception (oral contraceptives; inject able/implantable or mechanical devices as well as vasectomy of the sexual partner) for the entire duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.Orsola/Malpighi Teaching Hospital, University

Bologna, 40138, Italy

Location

Related Publications (3)

  • Zullo A, Gatta L, De Francesco V, Hassan C, Ricci C, Bernabucci V, Cavina M, Ierardi E, Morini S, Vaira D. High rate of Helicobacter pylori eradication with sequential therapy in elderly patients with peptic ulcer: a prospective controlled study. Aliment Pharmacol Ther. 2005 Jun 15;21(12):1419-24. doi: 10.1111/j.1365-2036.2005.02519.x.

    PMID: 15948808BACKGROUND

  • De Francesco V, Margiotta M, Zullo A, Hassan C, Troiani L, Burattini O, Stella F, Di Leo A, Russo F, Marangi S, Monno R, Stoppino V, Morini S, Panella C, Ierardi E. Clarithromycin-resistant genotypes and eradication of Helicobacter pylori. Ann Intern Med. 2006 Jan 17;144(2):94-100. doi: 10.7326/0003-4819-144-2-200601170-00006.

    PMID: 16418408BACKGROUND

  • Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V, Tampieri A, Morini S. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med. 2007 Apr 17;146(8):556-63. doi: 10.7326/0003-4819-146-8-200704170-00006.

    PMID: 17438314DERIVED

Study Officials

  • Dino Vaira, M.D.

    S.Orsola/Malpighi Teaching Hospital, University of Bologna, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

July 1, 2003

Study Completion

February 1, 2006

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

IT(1)