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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527605
• Other study ID #: ARI108898
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2007
• Last updated: March 15, 2012
• Start date: October 2007
• Est. completion date: March 2009

Study information

• Verified date: May 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Dutasteride 0.5mg capsule
Dutasteride 0.5mg once daily orally
• Dutasteride matched placebo
Dutasteride matched placebo once daily orally

Locations

Country	Name	City	State
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No