Condition category
Digestive System
Date applied
02/09/2013
Date assigned
07/10/2013
Last edited
08/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Helicobacter pylori (H. pylori) is a bacterium related to peptic ulcers and gastric cancer. Elimination of this bacterium is important to reduce the risk of diseases mentioned above. This study compares the effectiveness of two different eradication treatments.

Who can participate?
Patients with indigestion caused by H. pylori infection can participate in the study.

What does the study involve?
Patients will be randomly allocated to one of two treatment groups. Patients have to take pills of two different drug combinations based on the group to which they are allocated for 10 days.

What are the possible benefits and risks of participating?
Patients may benefit from indigestion relief, cure of the ulcers and prevention of gastric cancer. The risks due to the procedures and the side effects due to the drugs are low.

Where is the study run from?
The study is run in the outpatients gastroenterological unit of Hospital das Clinicas, São Paulo, Brazil.

When is study starting and how long is it expected to run for?
The study started in March 2013 and will finish in December 2013.

Who is funding the study?
The study is funded by Medley S.A. Indústria Farmacêutica and Hospital das Clínicas da Faculdade de Medicina da USP, Brazil.

Who is the main contact?
Dr Fernando Marcuz Silva
fernando.marcuz@hc.fm.usp.br

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jaime Eisig

ORCID ID

Contact details

Rua Albuquerque Lins 848
comp 112
Sao Paulo
01230-000
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Helicobacter pylori eradication: sequential versus classic triple therapy: a prospective randomized controlled double-blind study

Acronym

Study hypothesis

Due the increasing antibiotic resistance, sequential therapy can be an alternative to classic regime, in Helicobacter pylori eradication. But, in Brazil there are no works verifying the efficacy of the sequential and it is possible that classic regime still has good efficacy.

Ethics approval

University of Sao Paulo Ethical Commitee, 08/05/2013

Study design

Prospective randomized controlled double-blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Epigastric pain with normal or altered endoscopy

Intervention

100 peptic ulcer or functional dyspepsia patients randomized to two eradication regimens - two arms Helicobacter pylori eradication study:
1. Amoxicillin + clarithromycin + lansoprazole for 10 days
2. Amoxicillin + lanzoprazole 5 days, followed by clarithromycin + tinidazole + lansoprazole 5 days
Route of administration: Oral
The pills are packed in blisters and the control is done by counting of the pills from one of the investigators.

Intervention type

Drug

Phase

Not Applicable

Drug names

Amoxicillin, clarithromycin, lansoprazole and tinidazole

Primary outcome measures

1. Eradication rates
2. Cure rates will be achieved by endoscopy or UBT performed two months after the end of the treatment

Secondary outcome measures

Adverse effects are assessed by a questionnaire at the final visit

Overall trial start date

12/08/2013

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Outpatients with organic or functional dyspepsia
2. Aged between 18 and 80 years
3. Helicobacter pylori diagnosis confirmed by histology, rapid urease test or urea breath test (UBT)
4. No previous eradication history
5. Patients need to sign and understand the informed consent term

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Chronic or regular use of anabolic androgenic steroids (AAS) or non-steroidal anti-inflammatory drug (NSAID)
2. Recent antibiotic use (at least 30 days) before the study inclusion or before eradication control
3. Complicated peptic ulcer (Forrest I, Forrest II), bulbar stenosis
4. Pregnant or breastfeeding women
5. Previous gastric surgery
6. Consumptive renal, cardiac, hepatic insuficiency diseases

Recruitment start date

12/08/2013

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Albuquerque Lins 848, comp 112
Sao Paulo
01230-000
Brazil

Sponsor information

Organisation

Hospital das Clínicas da Faculdade de Medicina da USP (Brazil)

Sponsor details

Rua Dr. Ovídio Pires de Campos
225 - Cerqueira
César
Sao Paulo
05403-010
Brazil

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

The drugs are a courtesy of Medley S.A. Indústria Farmacêutica, Brazil but the tests are paid by Hospital das Clínicas da Faculdade de Medicina da USP, Brazil in routine care of patients with gastric diseases

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes