Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects
This study has been completed.
Information provided by (Responsible Party):
First received: August 24, 2006
Last updated: April 11, 2013
Last verified: May 2012
This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Clinical Evaluation of GI198745 in Benign Prostatic Hyperplasia- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 in Patients With Benign Prostatic Hyperplasia|
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.
Secondary Outcome Measures:
- Percent Change From Baseline in Prostate Volume at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.
- Number of Participants With IPSS Improvement From Baseline at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.
- Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.
- Number of Participants With Qmax Improvement From Baseline at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec
|Study Start Date:||February 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: Dutasteride||
|Placebo Comparator: Placebo||
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