Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01542567
Status:
UNKNOWN
Last Update Posted:
2012-05-22
First Post:
2012-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Diclofenac BCG Irrigations
Sponsor:
Carmel Medical Center
Organization:
Study Overview
Official Title:
Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
NOT_YET_RECRUITING
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:
DIC-2011
Brief Summary:
This study is designed to test the effectiveness of diclofenac suppositories in the prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.
Detailed Description:
This study is designed as a double blind placebo controlled randomized study to evaluate the effectiveness of diclofenac suppositories in the prevention of side effects of BCG bladder irrigation in bladder cancer patients. After signing an informed consent, the patients will be randomized to either receive an unmarked suppository of Diclofenac or a placebo suppository. The effectiveness of the drug will be tested weekly by quality of life questionnaires and bladder symptom questionnaire. Another questionnaire is designed to monitor the time in minutes that the BCG is retained in the bladder before the patients urinates.
Study Oversight
Has Oversight DMC:
False
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?: