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NCT01950403 · ClinicalTrials.gov registry record · Phase 1
Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers
A Phase 1 study of Colorectal Cancer and Healthy, no Evidence of Disease, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01950403: Completed Phase 1 study of Colorectal Cancer and Healthy, no Evidence of Disease, sponsored by Mayo Clinic.
NCT01950403 is a Phase 1 study of Colorectal Cancer and Healthy, no Evidence of Disease that has completed, run by Mayo Clinic. The registered enrollment target is 24 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01950403, a Phase 1 study of Colorectal Cancer and Healthy, no Evidence of Disease, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The pharmacological effect is measured by the arithmetic difference in mean cGMP levels before and after 7 days of linaclotide acetate in biopsies from the colonoscopy. The mean cGMP value will be calculated based on 2 biopsies from the rectum assessed at each time point. The PD response is measured by the difference in mean cGMP levels after 7 days.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- OTHER pharmacological study
- DRUG linaclotide acetate
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-09 |
| Est. Completion | 2018-02-22 |
| Phase | Phase 1 |
What the finished NCT01950403 record still lists
NCT01950403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01950403 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01950403 about?
NCT01950403 is a clinical study titled "Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers". 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.
What is the current status of trial NCT01950403?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-09. Estimated completion is 2018-02-22.
What conditions does trial NCT01950403 study?
This clinical trial studies the following conditions: Colorectal Cancer, Healthy, no Evidence of Disease.
What interventions are being tested in trial NCT01950403?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), pharmacological study (OTHER), linaclotide acetate (DRUG).
Who is sponsoring clinical trial NCT01950403?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01950403 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01950403's enrollment target sits among peer trials
24 333rd of 381 higher than 44 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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