Clinical trial NCT02483715: Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for First-line Treatment of Hp Infection
Official title: Efficacy of High-dose Dual Therapy Versus Bismuth-containing Quadruple Therapy for First-line Treatment of Helicobacter Pylori Infection - A Prospective, Randomized, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
high dose dual therapy
bismuth-containing quadruple therapy
antibiotic resistance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 589
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori eradication.

The aims of this study are:

1. to compare the efficacy of HDDT, and BQT as 1st-line regimen in H. pylori eradication;
2. to compare the patient adherence and adverse effects of these treatment regimens;
3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Detailed description: Participants, aged ≥ 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease teat, histology, and bacterial culture before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A, and B.

If the participants did not receive anti-H. pylori therapy previously, they will be invited to enter this study for evaluated the efficacy of these 1st-line regimens. Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens:

group A- HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);

group B- BQT ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days);

All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment.

Eligibility criteria: Inclusion criteria:

Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.

Exclusion criteria:

1. pregnant or nursing woman
2. serious concomitant illness and malignant tumor of any kind
3. history of hypersensitivity to test drugs
4. serious bleeding during the course of the ulcer
5. previous gastric surgery
6. receiving bismuth salts, PPIs, or antibiotics in the previous month.

Primary outcomes:
measure: The eradication rates as a measure of the efficacy of HDDT, and BQT
timeFrame: 3.5 years
Secondary outcomes:
measure: Number of participants with adverse effects as a measure of safety
timeFrame: 3.5 years
measure: Amount of unused medication post treatment as a measure of patient adherence.
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Chin Yang, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: