Last updated: 11/04/2018 04:44:01

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

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GSK study ID
ARI108898
See study documents
Clinicaltrials.gov ID
NCT00527605
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Percent change from baseline in the prostate volume at Month 6

Timeframe: Baseline and Month 6

Secondary outcomes:

Percent change from baseline in the prostate volume at Month 3

Timeframe: Baseline and Month 3

Change from baseline in the prostate volume at Month 6

Timeframe: Baseline and Month 6

Change from baseline in the prostate volume at Month 3

Timeframe: Baseline and Month 3

Percent change from baseline in the serum dihydrotestosterone (DHT) at Month 6

Timeframe: Baseline and Month 6

Percent change from baseline in the serum DHT at Month 3

Timeframe: Baseline and Month 3

Change from baseline in the serum DHT at Month 6

Timeframe: Baseline and Month 6

Change from baseline in the serum DHT at Month 3

Timeframe: Baseline and Month 3

Percent change from baseline in the American Urological Association Symptom Index (AUA-SI) score at Month 6

Timeframe: Baseline and Month 6

Percent change from baseline in the AUA-SI score at Month 3

Timeframe: Baseline and Month 3

Change from baseline in the AUA-SI score at Month 6

Timeframe: Baseline and Month 6

Change from baseline in the AUA-SI score at Month 3

Timeframe: Baseline and Month 3

Percent change from baseline in Maximum Urinary Flow Rate (Qmax) at month 6

Timeframe: Baseline and Month 6

Percent change from baseline in Qmax at Month 3

Timeframe: Baseline and Month 3

Change from baseline in Qmax at Month 6

Timeframe: Baseline and Month 6

Change from baseline in Qmax at Month 3

Timeframe: Baseline and Month 3

Interventions:
  • Drug: Dutasteride 0.5mg capsule
  • Drug: Dutasteride matched placebo
    • Enrollment:
    253
    Primary completion date:
    2009-23-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Na Y, Ye Z, Zhang S on behalf of the Chinese Dutasteride Phase III Trial (ARIA108898) Study Group. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia. [Clin Drug Invest]. 2012;32(1):29-39.
    Na Y, Ye Z, Zhang S on behalf of the Chinese Dutasteride Phase III Trial (ARIA108898) Study Group. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia. [Clin Drug Invest]. 2012;32(1):29-39.
    Medical condition
    Benign Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    October 2007 to March 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Inclusion:
    • Clinical diagnosis of BPH
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    BEIJING, China, 100050
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    GUANGZHOU, Guangdong, China, 510180
    Status
    Study Complete
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    Location
    GSK Investigational Site
    SHANGHAI, China, 200030
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    BEIJING, China, 100034
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    SHANGHAI, China, 200025
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    BEIJING, China
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 11 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-23-03
    Actual study completion date
    2009-23-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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