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NCT00314808 · ClinicalTrials.gov registry record · Phase 1

A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

A Phase 1 study, sponsored by Duke University.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target

NCT00314808: Completed Phase 1 study, sponsored by Duke University.

NCT00314808 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00314808, a Phase 1 study, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target

Study Summary

This study seeks to define the tolerability and safety associated with the administration of Dronabinol in the treatment of adults with nausea, vomiting and appetite loss in patients with primary gliomas who are undergoing chemotherapy treatment. The study will also describe the effect of Dronabinol on the quality of life in terms of nausea, vomiting and anorexia in this patient group.

Primary Outcome

Percentage of participants where the 2 cycles of Dronabinol is tolerable. The treatment regimen is considered intolerable if (1) at least two adverse events of the following types that are attributed to Dronabinol during the 2 cycles of treatment occur: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities, or (2) Dronabinol treatment is terminated early due to adverse events

Interventions

  • DRUG Dronabinol

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2006-04
Est. Completion 2012-04
Phase Phase 1
Duke University

1,725 total trials

What the finished NCT00314808 record still lists

NCT00314808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).

The record links to 0 conditions, and to 1 intervention - of which Dronabinol is the first listed.

NCT00314808 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00314808 about?

NCT00314808 is a clinical study titled "A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas". This study seeks to define the tolerability and safety associated with the administration of Dronabinol in the treatment of adults with nausea, vomiting and appetite loss in patients with primary gliomas who are undergoing chemotherapy treatment. The study will also describe the effect of Dronabinol...

What is the current status of trial NCT00314808?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2006-04. Estimated completion is 2012-04.

What interventions are being tested in trial NCT00314808?

The interventions under investigation include: Dronabinol (DRUG).

Who is sponsoring clinical trial NCT00314808?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00314808's enrollment target sits among peer trials

33 1280th of 2000 higher than 705 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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Source: ClinicalTrials.gov NCT00314808, the US trial registry maintained by the National Library of Medicine. NCT00314808 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.