Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001812
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
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
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0097 | None | None | None |