Clinical Trial: Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Evaluation of Dutasteride in Benign Prostatic Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 (Dutasteri

Brief Summary: This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52 [ Time Frame: Baseline and Week 52 ]

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.


Original Primary Outcome: Change from baseline in IPSS at week 52

Current Secondary Outcome:

  • Percent Change From Baseline in Prostate Volume at Week 52 [ Time Frame: Baseline and Week 52 ]
    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 ]
    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 ]
    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 ]
    Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec


Original Secondary Outcome: Percent change from baseline in prostate volume Proportion of subjects with IPSS improvement Change from baseline in peak urinary flow (Qmax) Proportion of subjects with Qmax improvement

Information By: GlaxoSmithKline

Dates:
Date Received: August 24, 2006
Date Started: February 2006
Date Completion:
Last Updated: April 17, 2014
Last Verified: February 2014