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NCT00392652 · ClinicalTrials.gov registry record · Phase 1
Diindolylmethane in Healthy Volunteers
A Phase 1 study of Healthy, no Evidence of Disease, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT00392652: Completed Phase 1 study of Healthy, no Evidence of Disease, sponsored by National Cancer Institute (NCI).
NCT00392652 is a Phase 1 study of Healthy, no Evidence of Disease that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 176-participant average among 11 other Healthy, no Evidence of Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00392652, a Phase 1 study of Healthy, no Evidence of Disease, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase I trial is studying the side effects and best dose of diindolylmethane in healthy volunteers. Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of diindolylmethane may keep cancer from forming. Collecting and storing samples of blood and urine from healthy volunteers to study in the laboratory may help doctors learn more about the way a person's body handles the drug.
Primary Outcome
Descriptive statistics will be calculated on all variables of interest: frequencies and percentages will be used to summarize categorical variables and medians, and ranges will summarize quantitative variables. Paired t-tests will be used to compare enzyme levels post-pre at each dose. Analysis of covariance will be used to determine if there is a dose effect on enzyme levels, using the baseline values as a covariate. If there is no dose effect, the seven subjects at each dose will be pooled whi
Conditions Studied
Interventions
- DRUG oral microencapsulated diindolylmethane
Study Locations (1)
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00392652 record still lists
NCT00392652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 176-participant average among 11 other Healthy, no Evidence of Disease trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Healthy, no Evidence of Disease appearing as the primary indexed condition, and to 1 intervention - of which oral microencapsulated diindolylmethane is the first listed.
NCT00392652 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT00392652 about?
NCT00392652 is a clinical study titled "Diindolylmethane in Healthy Volunteers". This randomized phase I trial is studying the side effects and best dose of diindolylmethane in healthy volunteers. Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of diindolylmethane may keep cancer from forming. Collecting and...
What is the current status of trial NCT00392652?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2006-11. Estimated completion is 2009-10.
What conditions does trial NCT00392652 study?
This clinical trial studies the following conditions: Healthy, no Evidence of Disease.
What interventions are being tested in trial NCT00392652?
The interventions under investigation include: oral microencapsulated diindolylmethane (DRUG).
Who is sponsoring clinical trial NCT00392652?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00392652 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy, no Evidence of Disease
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 NCT00392652's enrollment target sits among peer trials
14 11th of 11 higher than 1 of 11 other Healthy, no Evidence of Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy, no Evidence of Disease 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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