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NCT01133951
Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial
NA trial testing OAC triple therapy in Helicobacter Infections in 3,000 participants. Participants enrolled and being followed up; not accepting new ones.
1 January 2012
Quick facts
| Lead sponsor | Jie-Jun Wang |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 3,000 |
| Start date | 1 June 2010 |
| Primary completion | 1 January 2012 |
| Estimated completion | 1 May 2032 |
| Sites | 1 location across China |
Drugs / interventions tested
- OAC triple therapy — full drug profile →
- Placebo
Conditions studied
- Helicobacter Infections — all drugs for Helicobacter Infections →
- Stomach Neoplasms — all drugs for Stomach Neoplasms →
Sponsor
Jie-Jun Wang — full company profile →
Who can join
Adults 30 to 59, any sex, with Helicobacter Infections or Stomach Neoplasms. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Gastric cancer incidence
Time frame: 10 years
The incidence of gastric cancer in the two groups
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01133951
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Helicobacter Infections
Currently open trials in the same condition.
- NCT03365609 — A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01133951 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jie-Jun Wang
- Last refreshed: 9 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01133951.
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