Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers
NCT01950403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2024-12-09
Summary
This randomized phase I trial studies the side effects and best dose of linaclotide acetate in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal cancer.
Conditions
- Colorectal Cancer
- Healthy, no Evidence of Disease
Interventions
- DRUG
-
linaclotide acetate
Given PO
- OTHER
-
placebo
Given PO
- OTHER
-
pharmacological study
Correlative studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Paul Limburg · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2016-04-28
- Completion
- 2018-02-22
Countries
- United States
Study Locations
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