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Helicobacter Pylori Eradication to Prevent Gastric Cancer

NCT01133951 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2023-10-10

No results posted yet for this study

Summary

Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection appears to reduce the risk of gastric cancer. However, several recent controlled interventional trials by H. pylori eradication to prevent gastric cancer have yielded disappointing results. The exact effect of H.pylori eradication on prevention of gastric cancer is unclear up to now. To clarify this problem, the investigators conducted a prospective, randomized, double-blind, placebo-controlled, population-based study to determine whether H pylori eradication would reduce the incidence of gastric cancer in a high-risk population in China.

Conditions

  • Helicobacter Infections
  • Stomach Neoplasms

Interventions

DRUG

OAC triple therapy

Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.

DRUG

Placebo

Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.

Sponsors & Collaborators

  • Jie-Jun Wang

    lead OTHER

Principal Investigators

  • Jie J Wang, M.D. · Shanghai Changzheng Hospital affiliated to Second Military Medical University

  • Xi Wang, M.D. · Shanghai Changzheng Hospital affiliated to Second Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-01-31
Completion
2032-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01133951 on ClinicalTrials.gov