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NCT Number: NCT02483715

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

High-dose dual therapy (rabeprazole, amoxicillin)

Drug

High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)

Other names: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Amoxicillin ,Amoxicillin®

Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)

Drug

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)

Other names: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Metronidazole, Flagyl®, Antibiotics, Tetracycline, Tetracycline®, Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2015
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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