Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-Controlled Trial - Full Text View

Sponsor:	St. Orsola Hospital
Information provided by:	St. Orsola Hospital
ClinicalTrials.gov Identifier:	NCT00403364

Purpose

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.

Condition	Intervention	Phase
Helicobacter Pylori Infection	Drug: Placebo amoxicillin pantoprazole clarithromycin tinidazole	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-Controlled Trial

Resource links provided by NLM:

Drug Information available for: Tinidazole Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Clarithromycin Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

bacterial culture, and antibiotic resistance assessment

Estimated Enrollment:	300
Study Start Date:	July 2003
Estimated Study Completion Date:	February 2006

Detailed Description:

Background: Antimicrobial resistance has decreased eradication rates for H. pylori worldwide.

Objective: 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.

Design: Placebo-controlled trial. Setting: Two Italian Hospitals between September 2003 and April 2006. Patients: 300 dyspeptic or peptic ulcer patients Measurements: 13C urea breath test, upper endoscopy, histology, rapid urease test, bacterial culture, and antibiotic resistance assessment.

Intervention: 10-day sequential regimen (pantoprazole 40 mg, amoxicillin 1 g plus placebo for the first 5 days, followed by pantoprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg for the remaining 5 days) in 150 patients or standard 10-day therapy (pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g) in 150 patients. All drugs were given twice daily.

Results: There were 295 patients (Intent to treat) of whom 91% (95% CI: 86.5–95.7) had successful eradication with sequential therapy compared to 78% (95% CI: 71.2–84.5) for standard therapy (difference: 13.3%; 95%). The sequential therapy was significantly more effective in patients with clarithromycin resistant strains (88.9% patients vs. 28.6%; P = 0.0034). The incidence of major and minor side effects did not differ between therapy groups (17% vs. 17%).

Limitations: Follow-up was incomplete in 4.6% and 2.7% patients in sequential and standard therapy, respectively. The higher efficacy of sequential regimen should be confirmed outside Italy.

Conclusions: Sequential therapy is superior to conventional therapy for the eradication of H. pylori and it is significantly more effective in patients harbouring clarithromycin resistant strains.

The incidence side effects did not differ between therapy groups.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Helicobacter pylori infected patients > 18 years

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403364

Locations

Italy
S.Orsola/Malpighi Teaching Hospital, University
Bologna, Italy, 40138

Sponsors and Collaborators

St. Orsola Hospital

Investigators

Principal Investigator:

Dino Vaira, M.D.

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

More Information

Publications:

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Summary for patients in: Ann Intern Med. 2007 Apr 17;146(8):I20.

ClinicalTrials.gov Identifier:	NCT00403364 History of Changes
Other Study ID Numbers:	1112/2006, No grant received
Study First Received:	November 22, 2006
Last Updated:	November 22, 2006
Health Authority:	Italy: Ministry of Health

Keywords provided by St. Orsola Hospital:

Helicobacter pylori infection
Treatment
Double blind placebo controlled trial

Additional relevant MeSH terms:

Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Tinidazole
Pantoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012