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
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: clarithromycin Drug: tinidazole||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
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.
tinidazole-tetracycline-containing quadruple regimens
- 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.
- 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.
- The rate of adverse events happening [ Time Frame: 24 months ]Similarly, adverse events will also be measured by the Likert scale.
- The rate of good compliance [ Time Frame: 24 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): NCT04122287
|Contact: Xiuli Zuo, PhD,MD||15588818685 ext firstname.lastname@example.org|
|Jinan, Shandong, China, 250000|
|Principal Investigator:||Xiuli Zuo, PhD,MD||Qilu Hospital of Shandong University|