This trial is active, not recruiting.

Conditions helicobacter infections, stomach neoplasms
Treatments oac triple therapy, placebo
Sponsor Jie-Jun Wang
Start date June 2010
End date May 2020
Trial size 3000 participants
Trial identifier NCT01133951, SMMU20100501


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
oac triple therapy
Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.
(Placebo Comparator)
Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.

Primary Outcomes

Gastric cancer incidence
time frame: 10 years

Secondary Outcomes

Histopathological changes
time frame: 10 years

Eligibility Criteria

Male or female participants from 30 years up to 59 years old.

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

Additional Information

Official title Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial
Principal investigator Xi Wang, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Second Military Medical University.