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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01133951
Other study ID # SMMU20100501
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 2010
Est. completion date May 2032

Study information

Verified date October 2023
Source Second Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3000
Est. completion date May 2032
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 59 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China Zhao-Lai Hua M.D. Yangzhong City Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Jie-Jun Wang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastric cancer incidence The incidence of gastric cancer in the two groups 10 years
Secondary Histopathological changes The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups 10 years
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