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Chemoprevention of Gastric Carcinogenesis

NCT02794428 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2024-10-16

Study results available
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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.

Conditions

Interventions

DRUG

Eflornithine

Eflornithine\*, 2 tablets, Oral, Daily for 18 months

OTHER

Eflornithine placebo

Eflornithine placebo, 2 tablets, Oral, Daily for 18 months

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer Prevention Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Doug Morgan, MD · Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter

  • Keith Wilson, MD · Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-19
Primary Completion
2022-12-20
Completion
2024-07-01

Countries

  • Honduras
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02794428 on ClinicalTrials.gov