Clinical trial
Phase 4, Prospective, Randomized and Comparative Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice
Name
SEQvsCONC (TRA-047)
Description
Helicobacter pylori is the main cause of chronic gastritis, peptic ulcer and gastric tumors (adenocarcinoma and lymphoma). The cure of the H. pylori infection prevents recurrence of duodenal and gastric ulcer and improves dyspepsia in a significant proportion of cases, so it is cost-effective.
Eradication therapy has changed over time. The usually recommended pattern in the consensus conferences has traditionally been triple therapy, composed by the combination of 2 antibiotics (clarithromycin plus amoxicillin or metronidazole) and a proton pump inhibitor (PPI) for 7-14 days. Recent meta-analyses have that the current global eradication rate after standard triple therapy is less than 80%. Several European studies have found even lower eradication rates, with 35-40% of cases resulting in treatment failure. Treatment failure leads to a second treatment and a new diagnostic test to confirm eradication.
Trial arms
Trial start
2010-12-01
Estimated PCD
2012-06-01
Trial end
2012-07-01
Status
Completed
Phase
Early phase I
Treatment
PPI, amoxicillin, metronidazole and clarithromycin
Dual therapy for 5 days: PPI and 1g amoxicillin every 12h. After dual therapy continue with a triple therapy for 5 days: PPI, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h.
Arms:
Sequential treatment:
PPI, amoxicillin, metronidazole and clarithromycin
Quadruple therapy for ten days:PPI, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h
Arms:
Concomitant treatment
Size
338
Primary endpoint
"Intention to treat" eradication rates
One year
Eligibility criteria
Inclusion Criteria:
* Inclusion of patients with dyspepsia or peptic gastroduodenal ulcer for whom eradication treatment is indicated.
* Requirement of confirmation of the diagnosis of H. pylori infection by at least one positive test out of the following: breath test, histology, rapid urease test or culture.
Exclusion Criteria:
* Age less than 18 years.
* Advanced chronic disease or any other pathology that prevents attending controls and follow up.
* Allergy to any of the antibiotics in the treatment.
* Previous gastric surgery
* Pregnancy and lactation.
* History of alcohol or drug abuse.
* Previous eradication treatment.
* Consumption of antibiotics or bismuth salts during the last 4 weeks
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 338, 'type': 'ACTUAL'}}
Updated at
2023-09-26
1 organization
2 products
1 indication
Indication
Helicobacter pylori