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Clinical Trials in China / NCT01133951
Active, not recruiting Not applicable

Helicobacter Pylori Eradication to Prevent Gastric Cancer

NCT01133951 · tracked via the Priya Life Science China tracker
Sponsor
Jie-Jun Wang
Phase
Not applicable
Started
2010-06
Last updated
2023-10-10

Condition(s) studied

Helicobacter InfectionsStomach Neoplasms

Investigational drug(s) / intervention(s)

OAC triple therapyPlacebo

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

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

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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
59 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy registered inhabitants from 10 villages in a high-risk county of gastric cancer in China * Age 30-59 years * A willingness to participate in the study as indicated by written informed consent Exclusion Criteria: * Severe concomitant illness (eg, severe hypertension, coronary heart disease, diabetes mellitus, stroke, asthma, liver cirrhosis, tuberculosis, infectious hepatitis, and cardiac, respiratory, hepatic, or renal insufficiency) * Patients with epilepsy or severe mental illness * Previous diagnosis of cancer * A history of esophageal or gastric surgery * Drug abuse and drug dependence * Allergic to omeprazole, amoxicillin, or clarithromycin * Pregnant and lactating women * Previous history of H pylori eradication treatment * A negative 13C-urea breath test (UBT) * A definite indication of H. pylori eradication (eg, gastric or duodenum ulcer) * Dysplasia or carcinoma lesions are found in esophageal or gastric histopathological examination * Other factors or conditions might influence the results of study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhao-Lai Hua M.D. Yangzhong Jiangsu

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01133951 on ClinicalTrials.gov ↗ ← All trials in China