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
Verified date | May 2011 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
China,
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
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 |
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