Helicobacter pylori eradication - which is the best regimen: classic triple therapy or sequential therapy?

ISRCTN ISRCTN62400496
DOI https://doi.org/10.1186/ISRCTN62400496
Secondary identifying numbers N/A
Submission date
02/09/2013
Registration date
07/10/2013
Last edited
17/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Jaime Eisig
Scientific

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

Study information

Study designProspective randomized controlled double-blind study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleHelicobacter pylori eradication: sequential versus classic triple therapy: a prospective randomized controlled double-blind study
Study objectivesDue 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(s)University of Sao Paulo Ethical Commitee, 08/05/2013
Health condition(s) or problem(s) studiedEpigastric pain with normal or altered endoscopy
Intervention100 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Amoxicillin, clarithromycin, lansoprazole and tinidazole
Primary outcome measure1. Eradication rates
2. Cure rates will be achieved by endoscopy or UBT performed two months after the end of the treatment
Secondary outcome measuresAdverse effects are assessed by a questionnaire at the final visit
Overall study start date12/08/2013
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Total final enrolment100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment12/08/2013
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Brazil

Study participating centre

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

Sponsor information

Hospital das Clínicas da Faculdade de Medicina da USP (Brazil)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/03se9eg94

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2015 17/12/2020 Yes No

Editorial Notes

17/12/2020: Publication reference and total final enrolment added.