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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hospital Universitario de la Princesa.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de la Princesa
ClinicalTrials.gov Identifier:
NCT01273441
First received: January 7, 2011
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 Hospital Universitario de la Princesa:

Primary Outcome Measures:
  • "Intention to treat" eradication rates [ Time Frame: One year ] [ Designated as safety issue: No ]
    "Intention-to-treat" eradication of infection.


Secondary Outcome Measures:
  • "Per protocol" Eradication rate [ Time Frame: One year ] [ Designated as safety issue: No ]
    "Per protocol" eradication of infection.

  • Compliance [ Time Frame: One year ] [ Designated as safety issue: No ]
    Treatment compliance

  • Adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Adverse events

  • Clinical and demographic variables [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273441

Contacts
Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es

Locations
Spain
Hospital del Mar Not yet recruiting
Barcelona, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Felipe Bory Ros, Physician Doctor         
Hospital San Pedro de Alcántara Not yet recruiting
Cáceres, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Javier Molina Infante, Physician Doctor         
Hospital de Cabueñes Not yet recruiting
Gijón, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Cristobal de la Coba, Physician Doctor         
Hospital San Jorge Not yet recruiting
Huesca, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Miguel Montoro, Physician Doctor         
Hospital Universitario de La Princesa Recruiting
Madrid, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Dr. Javier P. Gisbert, Physician Doctor         
Hospital Costa del Sol Not yet recruiting
Málaga, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Ángeles Pérez Aisa, Physician Doctor         
Hospital de Sabadell Not yet recruiting
Sabadell, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Xavier Calvet, Physician Doctor         
Hospital Universitario de Valme Not yet recruiting
Sevilla, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Manuel Castro, Physician Doctor         
Hospital Mútua de Terrassa Not yet recruiting
Terrassa, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Montserrat Forne, Physician Doctors         
Hospital Universitario Río Hortega Not yet recruiting
Valladolid, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Jesús Barrio, Physician Doctor         
Hospital Clínico Universitario "Lozano Blesa" Not yet recruiting
Zaragoza, Spain
Contact: Javier P. Gisbert, Physician Doctor    +34 913093911    gisbert@meditex.es   
Principal Investigator: Julio Ducóns, Physician Doctor         
Sponsors and Collaborators
Hospital Universitario de la Princesa
Investigators
Principal Investigator: Javier P. Gisbert, Physician Doctor Digestive Service, Hospital Universitario de La Princesa
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitario de la Princesa
ClinicalTrials.gov Identifier: NCT01273441     History of Changes
Other Study ID Numbers: SEQvsCONC (TRA-047)
Study First Received: January 7, 2011
Last Updated: December 5, 2011
Health Authority: Drug Agency in Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Amoxicillin
Clarithromycin
Metronidazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014