Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568718
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Efficacy and Safety of Longidaze in the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Parallel Controlled Prospective Open-label Study of the Efficacy and Safety of Longidaze Lyophilisate for Solution for Injections and Rectal Suppositories 3000 IU in the Combined Treatment of Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAM
Brief Summary:
The goal of this clinical trial is to learn if Longidaze works to treat lower urinary tract symptoms in adult males with benign prostatic hyperplasia It will also learn about the safety of Longidaze The main question it aims to answer is
Does addition of Longidaze to tamsulosin lower the severity of symptoms assessed by International Prostate Symptom Score
What medical problems do participants have under the combined treatment by Longidaze and tamsulosin
Researchers will compare combined therapy Longidaze tamsulosin with monotherapy tamsulosin only to see if the combination works better
Participants will
Take tamsulosin 04mg every day for 130 days
In combined therapy arm -- make intramuscular injections of Longidaze every 5 days 5 injections then apply Longidaze rectal suppositories every 3 days 10 applications then apply Longidaze rectal suppositories every 7 days 10 applications
Visit the clinic on day 1 261 601 1303 for checkups and tests
Does addition of Longidaze to tamsulosin lower the severity of symptoms assessed by International Prostate Symptom Score
What medical problems do participants have under the combined treatment by Longidaze and tamsulosin
Researchers will compare combined therapy Longidaze tamsulosin with monotherapy tamsulosin only to see if the combination works better
Participants will
Take tamsulosin 04mg every day for 130 days
In combined therapy arm -- make intramuscular injections of Longidaze every 5 days 5 injections then apply Longidaze rectal suppositories every 3 days 10 applications then apply Longidaze rectal suppositories every 7 days 10 applications
Visit the clinic on day 1 261 601 1303 for checkups and tests
Detailed Description:
None
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