Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for First-line Treatment of Hp Infection

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483715
• Other study ID #: 201503120MIND
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: May 2018

Study information

• Verified date: March 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• High-dose dual therapy (rabeprazole, amoxicillin)
High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)
• Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)
Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The eradication rates as a measure of the efficacy of HDDT, and BQT	The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.	3.5 years
Secondary	Number of participants with adverse effects as a measure of safety	The safety will be evaluated by counting the number of participant with adverse events.	3.5 years
Secondary	Amount of unused medication post treatment as a measure of patient adherence.	The patient adherence will be evaluated by counting unused medication after the treatment.	3.5 years