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NCT00001812 · ClinicalTrials.gov registry record · Phase 3

A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
84
Enrollment target

NCT00001812: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00001812 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00001812, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
84 participants
Enrollment target

Study Summary

In patients who are receiving intravenous high dose Interleukin-2, patients will be randomized into two groups: group one will receive nystatin swish and swallow immediately before initiation of IL-2, and the second group will receive a placebo. The patients in each group will be monitored and evaluated for differences in the rate and severity of development of oral irritation during treatment. They will also be studied for differences between the two groups in the number of doses of IL-2 taken.

Interventions

  • DRUG Nystatin

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 1999-04
Est. Completion 2000-08
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001812 record still lists

NCT00001812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).

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

NCT00001812 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001812 about?

NCT00001812 is a clinical study titled "A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2". In patients who are receiving intravenous high dose Interleukin-2, patients will be randomized into two groups: group one will receive nystatin swish and swallow immediately before initiation of IL-2, and the second group will receive a placebo. The patients in each group will be monitored and evalu...

What is the current status of trial NCT00001812?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 1999-04. Estimated completion is 2000-08.

What interventions are being tested in trial NCT00001812?

The interventions under investigation include: Nystatin (DRUG).

Who is sponsoring clinical trial NCT00001812?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001812's enrollment target sits among peer trials

84 1749th of 2000 higher than 250 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00001812, the US trial registry maintained by the National Library of Medicine. NCT00001812 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.