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

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.

Study Overview

• Status: Withdrawn
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Esomeprazole; Drug: Amoxicillin; Other: Food effect; Drug: Clarythromycin

Detailed Description

Phase IV, open, randomized, prospective study.

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

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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	Drug: Esomeprazole; Drug: Amoxicillin; Other: Food effect; 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	Drug: Esomeprazole; Drug: Amoxicillin; Other: Food effect; 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	Drug: Esomeprazole; Drug: Amoxicillin; Other: Food effect; Drug: Clarythromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of H pylori eradication	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
side effects in each of the forms of triple therapy administration and compare them	7 days

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Principal Investigator: Decio Chinzon, Phd, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Amoxicillin; Clarithromycin; Esomeprazole
• Other Study ID Numbers: TIMESO