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NCT02365480 · ClinicalTrials.gov registry record · Phase 1
Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02365480: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02365480 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02365480, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This randomized, pilot phase I trial studies the side effects of berberine chloride in treating patients with ulcerative colitis and who are in remission (a decrease in or disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer. Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or coming back. The use of berberine chloride may keep colorectal cancer from forming in patients with ulcerative colitis.
Primary Outcome
Relevant counts and rates will be evaluated and reported by standard clinical tests. Symptoms such as fever, fatigue, weight loss, appetite, stool frequency, bloody stool and other upper and lower gastrointestinal tract symptoms in participants will be observed and recorded.
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Placebo Administration
- DRUG Berberine Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-06-16 |
| Est. Completion | 2019-12-13 |
| Phase | Phase 1 |
What the finished NCT02365480 record still lists
NCT02365480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02365480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02365480 about?
NCT02365480 is a clinical study titled "Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission". This randomized, pilot phase I trial studies the side effects of berberine chloride in treating patients with ulcerative colitis and who are in remission (a decrease in or disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer. Patients with ulcerative colitis are at ...
What is the current status of trial NCT02365480?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-06-16. Estimated completion is 2019-12-13.
What interventions are being tested in trial NCT02365480?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Placebo Administration (OTHER), Berberine Chloride (DRUG).
Who is sponsoring clinical trial NCT02365480?
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 NCT02365480's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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