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Trial record 16 of 215 for:    TETRACYCLINE

Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

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ClinicalTrials.gov Identifier: NCT04122287
Recruitment Status : Not yet recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief Summary:
We aim to assess and compare the effectiveness of clarithromycin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: clarithromycin Drug: tinidazole Phase 4

Detailed Description:

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin.

Therefore, our aim was to assess and compare the effectiveness of clarithromycin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: clarithromycin-tetracycline-containing quadruple group
patients in clarithromycin-tetracycline-containing quadruple group will receive lansoprazole 30mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 500mg po bid for 14d
Drug: clarithromycin
clarithromycin-tetracycline-containing quadruple regimens

Active Comparator: tinidazole-tetracycline-containing quadruple group
patients in tinidazole-tetracycline-containing quadruple group will receive lansoprazole 30mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and tinidazole 500mg po qid for 14d.
Drug: tinidazole
tinidazole-tetracycline-containing quadruple regimens




Primary Outcome Measures :
  1. Eradication rates in 2 groups [ Time Frame: 24 months ]
    Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.


Secondary Outcome Measures :
  1. The rate of improving dyspepsia symptoms after Helicobacter pylori eradication [ Time Frame: 24 months ]
    Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.

  2. The rate of adverse events happening [ Time Frame: 24 months ]
    Similarly, adverse events will also be measured by the Likert scale.

  3. The rate of good compliance [ Time Frame: 24 months ]
    Patients taken over 90% of drugs are considered to have a good compliance.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-70 with H. pylori infection; Patients Allergic to Penicillin.

Exclusion Criteria:

  • Patients with previous H. pylori eradication therapy; Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks; Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; Patients with known or suspected allergy to study medications; Currently pregnant or lactating; Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

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): NCT04122287


Contacts
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Contact: Xiuli Zuo, PhD,MD 15588818685 ext 053188369277 zuoxiuli@sina.com

Locations
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China, Shandong
Qilu hospital
Jinan, Shandong, China, 250000
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Xiuli Zuo, PhD,MD Qilu Hospital of Shandong University

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Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
ClinicalTrials.gov Identifier: NCT04122287     History of Changes
Other Study ID Numbers: 2019-SDU-QILU-G709
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 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:
Allergic
Penicillin
Helicobacter pylori
Eradication
Tetracycline
Additional relevant MeSH terms:
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Tetracycline
Clarithromycin
Penicillins
Tinidazole
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
Alkylating Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents