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Phase 4, Prospective, Randomized and Comparative Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice

Phase 4
18 Years
Open (Enrolling)
Helicobacter Pylori

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Trial Information

Phase 4, Prospective, Randomized and Comparative Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice

Justification of the study:

One of the latest therapeutic innovations is sequential therapy, introduced in Italy by
Zullo et al. The drug delivery strategy involves a 5-day induction phase with dual therapy
(a PPI every 12 hours and amoxicillin 1g every 12 hours), followed immediately by triple
therapy for 5 days with a PPI every 12 hours, metronidazole 500 mg every 12 hours and
clarithromycin 500 mg every 12 hours. Sequential therapy has proved more effectiveness than
standard triple therapy for seven and ten days. In order to assess the efficacy of this new
treatment in our area, over the past year we conducted a multicentre observational pilot
study in routine clinical practice conditions in patients infected with H. pylori and with
indications for eradication. 139 patients from 6 different centres were included. Excellent
treatment compliance and minimal side effects, similar to those described with triple
therapy, were shown. The results confirm similar efficacy to that obtained in previous
studies and an eradication rate significantly higher than that obtained with classic triple
therapy in our area.

Several previous studies have shown excellent efficacy of quadruple therapy with a PPI,
amoxicillin, clarithromycin and metronidazole, administering "concomitantly" the same drugs
as those of sequential therapy, but only for 5-7 days. Several studies have found a higher
eradication rate of this "concomitant" therapy as compared with classic triple therapy. The
results of a randomized study in which sequential and concomitant therapy were compared have
recently been reported in the American Congress of Gastroenterology. Eradication and adverse
events rates were similar with both treatments. This data suggest that the
"sequentially"administration of these drugs probably complicated unnecessarily the

Therefore it is necessary to make a controlled clinical trial to directly compare
"sequential" versus "concomitant" therapy. The results of this study will conclude which
should be the first line treatment for H. pylori eradication.

Inclusion Criteria:

- Inclusion of patients with dyspepsia or peptic gastroduodenal ulcer for whom
eradication treatment is indicated.

- Requirement of confirmation of the diagnosis of H. pylori infection by at least one
positive test out of the following: breath test, histology, rapid urease test or

Exclusion Criteria:

- Age less than 18 years.

- Advanced chronic disease or any other pathology that prevents attending controls and
follow up.

- Allergy to any of the antibiotics in the treatment.

- Previous gastric surgery

- Pregnancy and lactation.

- History of alcohol or drug abuse.

- Previous eradication treatment.

- Consumption of antibiotics or bismuth salts during the last 4 weeks

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

"Intention to treat" eradication rates

Outcome Description:

"Intention-to-treat" eradication of infection.

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Javier P. Gisbert, Physician Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Digestive Service, Hospital Universitario de La Princesa


Drug Agency in Spain: Agencia EspaƱola de Medicamentos y Productos Sanitarios

Study ID:




Start Date:

December 2010

Completion Date:

July 2012

Related Keywords:

  • Helicobacter Pylori