Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection
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|ClinicalTrials.gov Identifier: NCT03726099|
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: rabeprazole, amoxicillin, furazolidone，tetracycline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori: A Pilot Study|
|Estimated Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||March 30, 2020|
Experimental: 14d concomitant therapy
Patients will receive a 14-day concomitant therapy containing rabeprazole, amoxicillin, tetracycline and furazolidone.
Drug: rabeprazole, amoxicillin, furazolidone，tetracycline
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day concomitant therapy containing rabeprazole 10mg bid, amoxicillin 1000mg bid , furazolidone 100mg bid and tetracycline 500mg qid.
- Eradication rates [ Time Frame: 6 months ]Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all the 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.
- The rate of adverse events happening [ Time Frame: 6 months ]Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
- Changes of dyspepsia symptoms after Helicobacter pylori eradication [ Time Frame: 6 months ]A list of dyspepsia symptoms will be recorded. Difference of dyspepsia symptoms before and after the therapy will be compared.
- The rate of good compliance [ Time Frame: 6 months ]Patients taken over 90% of drugs are considered to have a good compliance.
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): NCT03726099
|Contact: Xiuli Zuo, MD,PhD||8653182169025 ext firstname.lastname@example.org|
|Contact: Xiuli Zuo, MD，PhD||8653182169025 ext email@example.com|
|Jinan, Shandong, China|
|Principal Investigator:||Xiuli Zuo, MD,PhD||Qilu Hospital of Shandong University|