Helicobacter Pylori Eradication to Prevent Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jie-Jun Wang, Second Military Medical University
ClinicalTrials.gov Identifier:
NCT01133951
First received: May 28, 2010
Last updated: January 3, 2014
Last verified: January 2014

May 28, 2010
January 3, 2014
June 2010
May 2020   (final data collection date for primary outcome measure)
Gastric cancer incidence [ Time Frame: 10 years ] [ Designated as safety issue: No ]
The incidence of gastric cancer in the two groups
Same as current
Complete list of historical versions of study NCT01133951 on ClinicalTrials.gov Archive Site
Histopathological changes [ Time Frame: 10 years ] [ Designated as safety issue: No ]
The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups
Same as current
Not Provided
Not Provided
 
Helicobacter Pylori Eradication to Prevent Gastric Cancer
Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Helicobacter Infections
  • Stomach Neoplasms
  • 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.
  • Experimental: OAC triple therapy
    Intervention: Drug: OAC triple therapy
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
May 2020
May 2020   (final data collection date for primary outcome measure)

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
Both
30 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01133951
SMMU20100501
Yes
Jie-Jun Wang, Second Military Medical University
Jie-Jun Wang
Not Provided
Study Chair: Jie J Wang, M.D. Shanghai Changzheng Hospital affiliated to Second Military Medical University
Principal Investigator: Xi Wang, M.D. Shanghai Changzheng Hospital affiliated to Second Military Medical University
Second Military Medical University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP