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

NCT02552641 | Withdrawn Phase 4 DMC

• 1 other identifier: TIMESO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Rate of H pylori eradication

  7 days

Secondary Outcomes (1)

• side effects in each of the forms of triple therapy administration and compare them

  7 days

Study Arms (3)

Test 1

EXPERIMENTAL

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

Test 2

EXPERIMENTAL

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

Test 3

EXPERIMENTAL

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

Interventions

Food effect OTHER

Test 1; Test 2; Test 3

Esomeprazole DRUG

Test 1; Test 2; Test 3

Amoxicillin DRUG

Test 1; Test 2; Test 3

Clarythromycin DRUG

Test 1; Test 2; Test 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Universidade de São Paulo

São Paulo, Brazil

Location

MeSH Terms

Interventions

Esomeprazole; Amoxicillin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Decio Chinzon, Phd

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

BR (1)