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Trial record 17 of 395 for:    CLARITHROMYCIN

A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients

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ClinicalTrials.gov Identifier: NCT04101708
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief Summary:
The purpose of this study is to assess and compare the effectiveness and safety of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients for eradicating H.pylori.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Drug: Lansoprazole, Amoxicillin Drug: Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate Phase 4

Detailed Description:

Helicobacter pylori plays an important role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori remains high in developing countries,including China.

Clarithromycin-containing bismuth quadruple therapy has been recommended as the first-line therapy for H pylori infection in China. However, its expensive cost and high antibiotic‐related adverse reactions are always haunting us. In 2018,a research from NanFang hospital(China)revealed that 250mg clarithromycin is as effective as 500mg clarithromycin,at the same time,causes less adverse reactions. On the othe hand,previous studies reported a new regimen called large dose dual therapy(generally contains a PPI and amoxicillin),while some of them have achieved very good results,especially in Taiwan.

However, specific data on anti-H.pylori treatments in elderly people are very lacking.So,we aim to assess and compare the effectiveness and tolerability of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients.Considering the difference of drug metabolism between eldery and young people,a satisfactory result may be obtained.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients
Estimated Study Start Date : September 20, 2019
Estimated Primary Completion Date : September 20, 2021
Estimated Study Completion Date : September 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: high dose dual group
Patients in high dose dual group will receive lansoprazole (Takepron) 30mg po qid, amoxicillin 750mg po qid for 14d
Drug: Lansoprazole, Amoxicillin
high dose dual regimen

Active Comparator: half-dose clarithromycin-containing bismuth quadruple group
Patients in half-dose clarithromycin-containing bismuth quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 250mg po bid for 14d
Drug: Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate
half-dose clarithromycin-containing bismuth quadruple regimen




Primary Outcome Measures :
  1. eradication rate of the two groups [ Time Frame: 24 months ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients, aged greater than 65 , with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

  • Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Information from the National Library of Medicine

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): NCT04101708


Contacts
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Contact: Xiuli Zuo, MD,PhD 15588818685 ext 15588818685 zuoxiuli@sina.com

Locations
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China, Shandong
Qilu hosipital Recruiting
Jinan, Shandong, China, 257000
Contact: Xiuli Zuo, MD,PhD    15588818685 ext 053188369277    zuoxiuli@sina.com   
Sub-Investigator: Boshen Lin, MD         
Sub-Investigator: Yueyue Li, MD,PhD         
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Xiuli Zuo, MD,PhD Qilu Hospital of Shandong University

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Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
ClinicalTrials.gov Identifier: NCT04101708     History of Changes
Other Study ID Numbers: 2019SDU-QILU-G099
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiuli Zuo, Shandong University:
elderly,helicobacter pylori eradication,dual therapy,half-dose clarithromycin
Additional relevant MeSH terms:
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Clarithromycin
Amoxicillin
Bismuth tripotassium dicitrate
Lansoprazole
Dexlansoprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective 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
Antacids