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OpenTrials
Completed

NCT Number: NCT02776371

Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

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

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Key information

Conditions

Helicobacter Pylori Eradication Rate

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified non-clarithromycin triple therapy

Drug

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.

sequential therapy

Drug

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 outcomes

  1. the difference of eradication rates between 2 groups

    Time frame: 5 months

Secondary outcomes

  1. the different rates of adverse events between 2 groups

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 18, 2016
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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