Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for Rescue Treatment of Hp Infection
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|ClinicalTrials.gov Identifier: NCT02490839|
Recruitment Status : Active, not recruiting
First Posted : July 7, 2015
Last Update Posted : March 26, 2019
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 rescue regimens for H. pylori eradication.
The aims of this study are:
- to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication;
- to compare the patient adherence and adverse effects of these treatment regimens;
- to investigate factors that may influence H. pylori eradication by these treatment regimens.
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: High-dose dual therapy (rabeprazole, amoxicillin) Drug: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)||Phase 4|
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 patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of High-dose Dual Therapy Versus Bismuth-containing Quadruple Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective, Randomized, Comparative Study|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: High-dose dual therapy
group A-high-dose dual therapy ( rabeprazole 20 mg, tablet, qid + amoxicillin 750 mg, capsule, qid for 14 days)
Drug: High-dose dual therapy (rabeprazole, amoxicillin)
High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)
Active Comparator: Bismuth-containing quadruple therapy
group B-bismuth-containing quadruple therapy (rabeprazole 20 mg, tablet, bid + tripotassium dicitrate bismuthate 300 mg, tablet, qid + metronidazole 250 mg, tablet, qid + tetracycline 500 mg qid, capsule, for 10 days)
Drug: 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)
- The eradication rates as a measure of the efficacy of HDDT, and BQT [ Time Frame: 3.5 years ]The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
- Number of participants with adverse effects as a measure of safety [ Time Frame: 3.5 years ]The safety will be evaluated by counting the number of participant with adverse events.
- Amount of unused medication post treatment as a measure of patient adherence. [ Time Frame: 3.5 years ]The patient adherence will be evaluated by counting unused medication after the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490839
|National Taiwan University Hospital|
|Taipei, Taiwan, 10002|
|Principal Investigator:||Jyh-Chin Yang, M.D.Ph.D.||National Taiwan University Hospital|