Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Identifier:
First received: January 7, 2011
Last updated: December 5, 2011
Last verified: December 2011

Helicobacter pylori is the main cause of chronic gastritis, peptic ulcer and gastric tumors (adenocarcinoma and lymphoma). The cure of the H. pylori infection prevents recurrence of duodenal and gastric ulcer and improves dyspepsia in a significant proportion of cases, so it is cost-effective.

Eradication therapy has changed over time. The usually recommended pattern in the consensus conferences has traditionally been triple therapy, composed by the combination of 2 antibiotics (clarithromycin plus amoxicillin or metronidazole) and a proton pump inhibitor (PPI) for 7-14 days. Recent meta-analyses have that the current global eradication rate after standard triple therapy is less than 80%. Several European studies have found even lower eradication rates, with 35-40% of cases resulting in treatment failure. Treatment failure leads to a second treatment and a new diagnostic test to confirm eradication.

Condition Intervention Phase
Helicobacter Pylori
Drug: PPI, amoxicillin, metronidazole and clarithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4, Prospective, Randomized and Comparative Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice

Resource links provided by NLM:

Further study details as provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:

Primary Outcome Measures:
  • "Intention to treat" eradication rates [ Time Frame: One year ]
    "Intention-to-treat" eradication of infection.

Secondary Outcome Measures:
  • "Per protocol" Eradication rate [ Time Frame: One year ]
    "Per protocol" eradication of infection.

  • Compliance [ Time Frame: One year ]
    Treatment compliance

  • Adverse events [ Time Frame: One year ]
    Adverse events

  • Clinical and demographic variables [ Time Frame: One year ]
    Age Sex Smoking habits Comorbidity (diabetes mellitus, arterial hypertension, ischemic heart disease, dyslipidemia, others) Indication for eradication (peptic ulcer vs. uninvestigated or functional dyspepsia) Initial diagnostic test for H. pylori infection.

Estimated Enrollment: 400
Study Start Date: December 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sequential treatment: Drug: PPI, amoxicillin, metronidazole and clarithromycin
Dual therapy for 5 days: PPI and 1g amoxicillin every 12h. After dual therapy continue with a triple therapy for 5 days: PPI, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h.
Experimental: Concomitant treatment Drug: PPI, amoxicillin, metronidazole and clarithromycin
Quadruple therapy for ten days:PPI, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h

Detailed Description:

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 treatment.

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 culture.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01273441

Hospital del Mar
Barcelona, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital de Cabueñes
Gijón, Spain
Hospital San Jorge
Huesca, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Costa del Sol
Málaga, Spain
Hospital de Sabadell
Sabadell, Spain
Hospital Universitario de Valme
Sevilla, Spain
Hospital Mútua de Terrassa
Terrassa, Spain
Hospital Universitario Río Hortega
Valladolid, Spain
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, Spain
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Principal Investigator: Javier P. Gisbert, Physician Doctor Digestive Service, Hospital Universitario de La Princesa
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Identifier: NCT01273441     History of Changes
Other Study ID Numbers: SEQvsCONC (TRA-047) 
Study First Received: January 7, 2011
Last Updated: December 5, 2011

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on January 19, 2017