Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-28 @ 11:16 PM
Study NCT ID:
NCT01756651
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures
Sponsor:
Richard C Reznichek, MD
Organization:
Study Overview
Official Title:
A Prospective Study Comparing the Efficacy and Safety of 100 mcg and 200 mcg of Intranasal Fentanyl Pectin Spray as an Analgesic in Adult Males Undergoing Outpatient Cystoscopic Procedures
Status:
COMPLETED
Status Verified Date:
2017-05
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:
The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.
Detailed Description:
In this prospective study, twenty subjects will be enrolled. The first ten will receive a dose of 100mcg pectin fentanyl nasal spray (Lazanda®). The second ten will receive a dose of 200mcg pectin fentanyl nasal spray (Lazanda®) if the 100mcg was well tolerated in the first ten. In all cases, Lidocaine jelly is used as an local anesthetic in the urethra.
Study Oversight
Has Oversight DMC:
True
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?: