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Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776371
Recruitment Status : Completed
First Posted : May 18, 2016
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Brief Summary:
Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Eradication Rate Drug: Modified non-clarithromycin triple therapy Drug: Sequential therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : September 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: Modified non-clarithromycin triple therapy
H.pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.
Drug: Modified non-clarithromycin triple therapy
H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.

Active Comparator: Sequential therapy
H.pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.
Drug: Sequential therapy
H. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.




Primary Outcome Measures :
  1. the difference of eradication rates between 2 groups [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. the different rates of adverse events between 2 groups [ Time Frame: 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent.

Exclusion Criteria:

  • negative in rapid urease test (RUT)
  • previous standard eradication therapy for H. pylori;
  • history of esophagectomy or gastrectomy;
  • gastrointestinal malignancy;
  • contraindications or allergic to study drugs;
  • user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.);
  • cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy;
  • pregnant or lactating women;
  • participants of other trial within the past 3 months;
  • unwilling or unable to participate in the study.

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): NCT02776371


Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Li Yanqing, MD, PhD Qilu Hospital of Shandong University
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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02776371    
Other Study ID Numbers: 2016SDU-QILU-05
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Keywords provided by Yanqing Li, Shandong University:
Helicobacter pylori
Sequential therapy
Modified non-clarithromycin triple therapy