Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-03-06 @ 12:52 AM
Study NCT ID:
NCT01757769
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2012-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia
Sponsor:
RECORDATI GROUP
Organization:
Study Overview
Official Title:
Effectiveness and Safety of Silodosin in the Treatment of LUTS in Patients With Benign Prostatic Hyperplasia: a European Phase IV Clinical Study. The Silodosin in Real-life Evaluation Study
Status:
COMPLETED
Status Verified Date:
2014-04
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:
SiRE
Brief Summary:
The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.
Detailed Description:
The objective of the study is to confirm in a larger and less selected population ("real life conditions") the positive risk-benefit balance observed with silodosin in double-blind, randomised clinical trials.
The following aspects will be evaluated:
* the effects on lower urinary tract symptoms (LUTS), by means of the International Prostate Symptoms Score (IPSS) questionnaire
* the effect on the most frequent and bothersome symptoms, by means of International Continence Society (ICS)-male questionnaire
* the effects on Quality of Life (QoL) due to urinary symptoms
* the safety profile
* the adherence to therapy
* the patient satisfaction with treatment The effectiveness and safety of the drug will be investigated also in different subgroups of subjects according to age, severity of the disease, concomitant disease and medications.
The following aspects will be evaluated:
* the effects on lower urinary tract symptoms (LUTS), by means of the International Prostate Symptoms Score (IPSS) questionnaire
* the effect on the most frequent and bothersome symptoms, by means of International Continence Society (ICS)-male questionnaire
* the effects on Quality of Life (QoL) due to urinary symptoms
* the safety profile
* the adherence to therapy
* the patient satisfaction with treatment The effectiveness and safety of the drug will be investigated also in different subgroups of subjects according to age, severity of the disease, concomitant disease and medications.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-000045-20 | EUDRACT_NUMBER | None | View |