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Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole

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ClinicalTrials.gov Identifier: NCT02552641
Recruitment Status : Unknown
Verified September 2015 by EMS.
Recruitment status was:  Recruiting
First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
EMS

Brief Summary:
The purpose of the study is assess whether the various forms of triple regimen of administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and any independent mealtime) influence the rate of eradication of this bacterium.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Other: Food effect Drug: Esomeprazole Drug: Amoxicillin Drug: Clarythromycin Phase 4

Detailed Description:

Phase IV, open, randomized, prospective study.

  • Length of experience: 180 days.
  • 06 visits.
  • Evaluation of the efficacy of differences regimens of administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole
Study Start Date : September 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test 1
Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, in fasting conditions, twice daily
Other: Food effect
Drug: Esomeprazole
Drug: Amoxicillin
Drug: Clarythromycin
Experimental: Test 2
Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, after meals, twice daily
Other: Food effect
Drug: Esomeprazole
Drug: Amoxicillin
Drug: Clarythromycin
Experimental: Test 3
Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, twice daily in schedules variables with an interval of at least 8 hours between the doses
Other: Food effect
Drug: Esomeprazole
Drug: Amoxicillin
Drug: Clarythromycin



Primary Outcome Measures :
  1. Rate of H pylori eradication [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. side effects in each of the forms of triple therapy administration and compare them [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants of both sexes;
  • Age greater than or equal to 18 and less than or equal to 50 years;
  • Participant diagnosed with type dyspepsia epigastric pain carriers of Helicobacter pylori infection, according to the classification of ROME III;
  • Ability to understand and consent to participate in this clinical study, manifested by reading, understanding and signing of the Informed Consent (IC).

Exclusion Criteria:

  • Any finding of clinical observation (clinical evaluation / physical) that is interpreted by the investigator as a medical risk to participate in the clinical trial;
  • Any laboratory examination found that the investigator doctor considers a risk to the research participant for their participation in the clinical trial;
  • Known hypersensitivity to the drug components used during the study;
  • Women in pregnancy or breastfeeding period;
  • Women in reproductive age who do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptive, IUD, hormonal implants, barrier methods, abstinence, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy);
  • Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it;
  • Party that has some kinship to the second degree or bond with employees or employees of Sponsor and Research Center;
  • Patients with predominant symptoms of reflux or irritable bowel syndrome, warning symptoms, peptic ulcer history or previous surgery in the upper segment of the gastrointestinal tract;
  • Patients with prior treatment history of eradication of Helicobacter pylori;
  • Patients with kidney, liver or heart failure;
  • Patients with past or current history of alcohol abuse;
  • Patients with a history of use of antibiotics or bismuth in the 4 weeks prior to study entry, PPIs or H2 blockers, NSAIDs or aspirin in the last two weeks;
  • Patients whose endoscopy show changes except hyperemic gastritis, erosive gastritis den considering the maximum of 5 erosions in this location or hiatal hernia;
  • Patients whose ultrasonography show hepato-biliopancreatic changes except steatosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552641


Contacts
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Contact: Christina Ecclissato, Md 55.19.38879433 christina.ecclissato@ems.com.br

Locations
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Brazil
Universidade de São Paulo Recruiting
São Paulo, Brazil
Contact: Decio Chinzon, MD         
Principal Investigator: Decio Chinzon, MD         
Sponsors and Collaborators
EMS
Investigators
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Principal Investigator: Decio Chinzon, Phd University of Sao Paulo

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02552641     History of Changes
Other Study ID Numbers: TIMESO
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Esomeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors