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NCT03300570 · ClinicalTrials.gov registry record · Phase 1
Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03300570: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03300570 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03300570, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This phase I trial studies how well dolcanatide works in preventing colorectal cancer in healthy participants. Dolcanatide is similar to a natural hormone released into the intestine. It is thought that people who have low levels of the hormone are more likely to get colon cancer. It may be possible to prevent colon cancer by giving a drug that is similar to the hormone, such as dolcanatide.
Primary Outcome
Pharmacological effect on cyclic guanosine monophosphate (cGMP) levels for dolcanatide arm versus (vs.) placebo, where this effect is defined as the arithmetic difference in mean cGMP levels before and after 7 days of dolcanatide from subject biopsies. This represents the increase in cGMP stimulated by 7 days of dolcanatide in an individual subject. The mean cGMP value will be calculated based on 6 biopsies collected from the rectum during a flexible sigmoidoscopy procedure. Each biopsy was anal
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- OTHER Placebo Administration
- DRUG Dolcanatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-07-27 |
| Est. Completion | 2021-05-17 |
| Phase | Phase 1 |
What the finished NCT03300570 record still lists
NCT03300570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03300570 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03300570 about?
NCT03300570 is a clinical study titled "Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers". This phase I trial studies how well dolcanatide works in preventing colorectal cancer in healthy participants. Dolcanatide is similar to a natural hormone released into the intestine. It is thought that people who have low levels of the hormone are more likely to get colon cancer. It may be possible...
What is the current status of trial NCT03300570?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-07-27. Estimated completion is 2021-05-17.
What interventions are being tested in trial NCT03300570?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Placebo Administration (OTHER), Dolcanatide (DRUG).
Who is sponsoring clinical trial NCT03300570?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03300570's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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