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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list