Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy (THC)
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ClinicalTrials.gov Identifier: NCT01607918 |
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : May 30, 2012
Last Update Posted : October 29, 2013
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Condition or disease | Intervention/treatment | Phase |
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Eradication Rates of the Two Regimens | Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole) Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
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Experimental: Sequential therapy 10 days
Sequential therapy
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Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)
D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
Other Names:
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Active Comparator: Triple therapy 14 days
Triple therapy
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Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin)
D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
Other Names:
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- Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis [ Time Frame: 6 weeks ]C13-UBT will be used to assess the existence of H. pylori
- Incidence of adverse effects [ Time Frame: during eradication therapy ]to assess the adverse effects

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
- Written informed consents will be obtained from all patients prior to enrollment.
Exclusion Criteria:
Patients will be excluded from the study if any one of the following criteria is present:
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
- pregnant or lactating women,
- severe concurrent disease
- Patients who cannot give informed consent by himself or herself.

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): NCT01607918
Contact: Jyh-Ming Liou, MD | 886-972651883 | dtmed046@pchome.com.tw |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei,, Taiwan, 10002 | |
Contact: Jyh-Ming Liou, MD 886-972651883 dtmed046@pchome.com.tw | |
Principal Investigator: Jyh-Ming Liou, MD |
Principal Investigator: | Jyh-Ming Liou, MD | National Taiwan University Hospital | |
Principal Investigator: | Ming-Shiang Wu, MD, PhD | National Taiwan University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Taiwan University Hospital, Doctor and Principle Investigator, Department of Gastroenterology |
ClinicalTrials.gov Identifier: | NCT01607918 |
Other Study ID Numbers: |
201110019MD |
First Posted: | May 30, 2012 Key Record Dates |
Last Update Posted: | October 29, 2013 |
Last Verified: | October 2013 |
H pylori, eradication |
Amoxicillin Metronidazole Clarithromycin Lansoprazole Dexlansoprazole Anti-Bacterial Agents Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |