Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

A Randomized, Double-blind, Placebo-controlled, Six-month Parallel-group Study to Assess Efficacy and Safety of Dutasteride 0.5mg Once Daily in Chinese Patients With Benign Prostatic Hyperplasia (BPH), Followed by a 12-month Open-label Treatment Phase

This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia; Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Dutasteride 0.5mg capsule; Drug: Dutasteride matched placebo

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • GSK Investigational Site
  • Beijing, China
    • GSK Investigational Site
  • Beijing, China, 100050
    • GSK Investigational Site
  • Beijing, China, 100853
    • GSK Investigational Site
  • Shanghai, China, 200025
    • GSK Investigational Site
  • Shanghai, China, 200030
    • GSK Investigational Site
  • Shanghai, China, 200001
    • GSK Investigational Site
  • Tianjin, China, 300211
    • GSK Investigational Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • GSK Investigational Site
  • Hubei
    • Wuhan, Hubei, China, 430030
      • GSK Investigational Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • GSK Investigational Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion:

• Clinical diagnosis of BPH
• AUA-SI >=12 [American Urological Association Symptom Index]
• Qmax > 5ml/sec and <=15ml/sec and minimum voided volume of >=125ml
• Prostate volume >=30cm(3)

Exclusion:

• Post void residual volume >250ml
• History or evidence of prostate cancer
• Total serum PSA <1.5ng/ml or >10.0ng/ml (Prostate specific antigen)
• Previous prostatic surgery or other invasive procedures to treat BPH.
• History of AUR (Acute Urinary Retention) within 3 months
• History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days
• Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate
• History of hepatic impairment or abnormal liver function tests
• Use of any 5a-reductase inhibitors ,any drugs with antiandrogenic properties or other drugs noted for gynaecomastia effects, or could affect prostate volume, within past 6 months and throughout the study
• Use of alpha-receptor blockers within 2 weeks and throughout the study.
• Use of phytotherapy for BPH within 2 weeks and/or predicted to need phytotherapy during the study.
• Concurrent use of anabolic steroids
• Use of any alpha-adrenergic agonists or cholinergics within 48 hours prior to uroflowmetry assessment.
• Hypersensitivity to any 5a-reductase inhibitor or other chemically-related drugs.
• Actively trying to procreate or unwilling to wear a condom during intercourse with a woman of childbearing potential for duration of participation in this study and 16 weeks following treatment.
• History or current evidence of drug or alcohol abuse within the previous 12 months.
• History of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
• Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, of cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
• History of renal insufficiency, or serum creatinine >1.5xULN (Upper Limit of Normal )
• Participation in any investigational or marketed drug trial within 30 days and during the course of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; dutasteride 0.5mg once daily orally	Drug: Dutasteride 0.5mg capsule; Dutasteride 0.5mg once daily orally
Placebo Comparator: B; Placebo matched once daily orally	Drug: Dutasteride matched placebo; Dutasteride matched placebo once daily orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in the Prostate Volume at Month 6	Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.	Baseline and Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in the Prostate Volume at Month 3	Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.	Baseline and Month 3
Change From Baseline in the Prostate Volume at Month 6	Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.	Baseline and Month 6
Change From Baseline in the Prostate Volume at Month 3	Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.	Baseline and Month 3
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6	Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.	Baseline and Month 6
Percent Change From Baseline in the Serum DHT at Month 3	Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.	Baseline and Month 3
Change From Baseline in the Serum DHT at Month 6	Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.	Baseline and Month 6
Change From Baseline in the Serum DHT at Month 3	Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.	Baseline and Month 3
Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6	Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.	Baseline and Month 6
Percent Change From Baseline in the AUA-SI Score at Month 3	Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.	Baseline and Month 3
Change From Baseline in the AUA-SI Score at Month 6	Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.	Baseline and Month 6
Change From Baseline in the AUA-SI Score at Month 3	Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.	Baseline and Month 3
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6	Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.	Baseline and Month 6
Percent Change From Baseline in Qmax at Month 3	Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.	Baseline and Month 3
Change From Baseline in Qmax at Month 6	Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.	Baseline and Month 6
Change From Baseline in Qmax at Month 3	Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.	Baseline and Month 3

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Na Y, Ye Z, Zhang S; Chinese Dutasteride Phase III Trial (ARIA108898) Study Group. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia: a randomized, double-blind, parallel-group, placebo-controlled study with an open-label extension. Clin Drug Investig. 2012 Jan 1;32(1):29-39. doi: 10.2165/11593750-000000000-00000.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 10, 2007
• First Submitted That Met QC Criteria: September 10, 2007
• First Posted (Estimate): September 11, 2007

Study Record Updates

• Last Update Posted (Estimate): March 21, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Chinese; Benign Prostatic Hyperplasia; Randomized; Dutasteride; Double blind; placebo control
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: ARI108898