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NCT00790478 · ClinicalTrials.gov registry record · Phase 2
Melatonin and Ulcerative Colitis: A Pilot Clinical Trial
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00790478 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 3 participants.
The verdict
NCT00790478, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain, fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body functions that may be related to health. Melatonin is produced in the pineal gland and, in fact, it is produced in even greater amounts in the gut. Melatonin appears to be important in gastrointestinal tract physiology and health, and data from cell and animal experiments, and some studies in humans, suggest that supplemental melatonin may help ameliorate colitis. Given that current treatments for ulcerative colitis are not always effective, and often have serious side effects, there is considerable interest in finding alternative treatments for this disease. However, experimental data on the ability of melatonin to improve ulcerative colitis in humans are lacking. To address this, we plan to conduct a pilot clinical trial (60 adult male and female participants) that will obtain preliminary data about the effectiveness of melatonin supplementation as a treatment for ulcerative colitis in adult men and women with the disease. The "Melatonin and Ulcerative Colitis" study funded by a grant from the Broad Foundation's Broad Medical Research Program (http://www.broadmedical.org).
Interventions
- OTHER Placebo
- DRUG Melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00790478
The ClinicalTrials.gov registry entry for NCT00790478 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00790478 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00790478 about?
NCT00790478 is a clinical study titled "Melatonin and Ulcerative Colitis: A Pilot Clinical Trial". Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain, fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body functions that may be re...
What is the current status of trial NCT00790478?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2009-01. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00790478?
The interventions under investigation include: Placebo (OTHER), Melatonin (DRUG).
Who is sponsoring clinical trial NCT00790478?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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