Chemoprevention of Gastric Carcinogenesis (NCT02794428) | Clinical Trial Compass
CompletedPhase 2
Chemoprevention of Gastric Carcinogenesis
Honduras, Puerto Rico91 participantsStarted 2016-09-19
Plain-language summary
A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America.
Who can participate
Age range30 Years – 69 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a history of a premalignant lesion of the stomach, atrophic gastritis or intestinal metaplasia
* Patients must have a pure tone audiometry evaluation to document air conduction within 60 days prior to randomization.
* Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days):
* Blood counts: WBC ≥4.0 /mcL, platelets ≥100,000 /mcL and hemoglobin ≥11.0 g/dL
* Kidney function: Creatinine \<1.6 x IULN (institutional upper limit of normal)
* Liver function tests: Bilirubin ≤2.0 mg/dL and AST (SGOT) or ALT (SGPT) ≤2 x IULN
Exclusion Criteria:
* Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation
* Patients must not have a significant medical or psychiatric condition that would preclude study completion.
* Patients with hearing loss ≥30 dB in any of the tested frequencies (250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz) are not eligible.
* Patients must not have known hypersensitivity to eflornithine or the excipients.
* Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
* Patients must not have a significant cardiovascular disease history, including uncontrolled blood pressure (sBP \> 150 mmHg), myocardial infarction, cerebrovascular accident, or heart failure (New York Heart Association Class III, or IV).
* Patients must not have a his…
What they're measuring
1
The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months.