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

Primary Purpose

Benign Prostatic Hyperplasia, Prostatic Hyperplasia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Dutasteride 0.5mg capsule
Dutasteride matched placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring placebo control, Chinese, Dutasteride, Randomized, Benign Prostatic Hyperplasia, Double blind

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

dutasteride 0.5mg once daily orally

Placebo matched once daily orally

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 10, 2007
Last Updated
March 15, 2012
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00527605
Brief Title
Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Prostatic Hyperplasia
Keywords
placebo control, Chinese, Dutasteride, Randomized, Benign Prostatic Hyperplasia, Double blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
dutasteride 0.5mg once daily orally
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo matched once daily orally
Intervention Type
Drug
Intervention Name(s)
Dutasteride 0.5mg capsule
Intervention Description
Dutasteride 0.5mg once daily orally
Intervention Type
Drug
Intervention Name(s)
Dutasteride matched placebo
Intervention Description
Dutasteride matched placebo once daily orally
Primary Outcome Measure Information:
Title
Percent Change From Baseline in the Prostate Volume at Month 6
Description
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.
Time Frame
Baseline and Month 6
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in the Prostate Volume at Month 3
Description
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.
Time Frame
Baseline and Month 3
Title
Change From Baseline in the Prostate Volume at Month 6
Description
Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Prostate Volume at Month 3
Description
Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.
Time Frame
Baseline and Month 3
Title
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Percent Change From Baseline in the Serum DHT at Month 3
Description
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.
Time Frame
Baseline and Month 3
Title
Change From Baseline in the Serum DHT at Month 6
Description
Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Serum DHT at Month 3
Description
Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.
Time Frame
Baseline and Month 3
Title
Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Percent Change From Baseline in the AUA-SI Score at Month 3
Description
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.
Time Frame
Baseline and Month 3
Title
Change From Baseline in the AUA-SI Score at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change From Baseline in the AUA-SI Score at Month 3
Description
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.
Time Frame
Baseline and Month 3
Title
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Percent Change From Baseline in Qmax at Month 3
Description
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.
Time Frame
Baseline and Month 3
Title
Change From Baseline in Qmax at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Qmax at Month 3
Description
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.
Time Frame
Baseline and Month 3

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
GSK Investigational Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
GSK Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
GSK Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
GSK Investigational Site
City
Beijing
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
GSK Investigational Site
City
Tianjin
ZIP/Postal Code
300211
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27933597
Citation
Na Y, Ye Z, Zhang S. 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;32(1):29-39. doi: 10.2165/11593750-000000000-00000.
Results Reference
background
PubMed Identifier
22017520
Citation
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.
Results Reference
derived

Learn more about this trial

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

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