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
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
Scientific
Rua Albuquerque Lins 848, comp 112
Sao Paulo
01230-000
Brazil
Study information
| Study design | Prospective randomized controlled double-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Helicobacter pylori eradication: sequential versus classic triple therapy: a prospective randomized controlled double-blind study |
| Study objectives | 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(s) | University of Sao Paulo Ethical Commitee, 08/05/2013 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 12/08/2013 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/08/2013 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Brazil
Study participating centre
01230-000
Brazil
Sponsor information
Hospital/treatment centre
Rua Dr. Ovídio Pires de Campos
225 - Cerqueira
César
Sao Paulo
05403-010
Brazil
"ROR" |
https://ror.org/03se9eg94 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
