At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
Dolcanatide +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Double-Blind, Placebo-Controlled Trial of 27 mg Dolcanatide (SP-333) to Demonstrate Colorectal Bioactivity in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Dolcanatide, Laboratory Biomarker Analysis, and 2 other interventions for Colorectal Carcinoma. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Carcinoma
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartJul 2018
Primary CompletionJan 2019
Study CompletionMay 2021
TodayJul 2026
First PostedOct 3, 2017
Enrollment StartJul 27, 2018
Primary CompletionJan 2, 2019
Study CompletionMay 17, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.7 years ago
Interventions
Dolcanatidedrug
Given PO
Laboratory Biomarker Analysisother
Correlative studies
Placebo Administrationother
Given PO
Questionnaire Administrationother
Ancillary studies