Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

Phase 3

Completed

Conditions: Prostatic Hyperplasia

Interventions: Drug: Dutasteride
Drug: Placebo

Registration Number: NCT00368979

Lead Sponsor: GlaxoSmithKline

Brief Summary: This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 378

Inclusion Criteria

Only subjects who meet all the following criteria during the screening phase will be enrolled in the study.

Diagnosis: BPH
Age: ≥50 years
Gender: Male
Estimated prostate volume ≥30cc (by TRUS)
I-PSS Symptom Score (total of 7 items) ≥8 points
Maximum flow rate (Qmax) ≤15mL/sec (voided volume measured simultaneously ≤150mL)*[1]
Patients who meet either of the following regarding tamsulosin HCl use:

Patients with tamsulosin HCl use:

Patients who have received tamsulosin HCl continuously for at least 4 weeks and who are likely to continue to take tamsulosin HCl without any change to the dosage and administration of the drug until the end of study treatment.

Patients without tamsulosin HCl use:

Patients who haven't received tamsulosin HCl in the past 4 weeks and who are unlikely to use tamsulosin HCl until the end of study treatment.
Outpatients
Patients who in person have given written consent

Exclusion Criteria

Patients who apply to any of the following criteria during the screening phase will not be enrolled in the study.

Post void residual volume >250mL (by suprapubic ultrasound).
History of AUR within the previous 12 weeks.
Evidence or history of prostate cancer.
PSA >10ng/mL [in patients with PSA >4ng/mL, the presence of prostate cancer should be ruled out by the investigator/subinvestigator. DRE and free/total PSA ratio should be considered, and prostate biopsy be conducted if necessary].
Previous surgery (including balloon dilatation, thermotherapy and stent placement) or minimally invasive techniques for BPH.
Any causes other than BPH, which may in the judgment of the investigator/subinvestigator, affect evaluation of symptoms or urine flow (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute/chronic prostatitis, acute/chronic urinary tract infection).
History of any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias*[2], congestive heart failure or cerebrovascular accident within the previous 6 months; or diabetes mellitus or peptic ulcer uncontrollable with medical treatment.
Liver function tests (AST, ALT, AL-P) >2 times the upper limit of normal.
Serum cleatinine >1.8mg/dL.
Use of any antiandrogen (e.g., chlormadinone acetate, allylesterenol) for BPH within the previous 12 months.
Use of a1-adrenoceptor blockers excluding tamsulosin HCl (e.g., prazosin HCl, urapidil slow-release capsule formulation, terazosin HCl, naftopidil), plant extract preparations for treatment of BPH (e.g., Eviprostat, cernitin pollen extract), herbal medicines (e.g., hachimi-jio-gan, gosha-jinki-gan), other drugs (e.g., Paraprost), and dietary or herbal supplements (e.g., saw palmetto) for relief of BPH symptoms within the previous 4 weeks.

Use of a-adrenoceptor agonists (e.g., pseudoephedrine, phenyle

[1] Subjects with voided volume <150 mL at Qmax measurement cannot be enrolled in the study and may undergo re-measurement of Qmax before the visit for Week 0 for study entry.
[2] Of "Degree II" according to "Grading of Side Effects (PMSB Notification No. 80 dated June 29, 1992) or equivalent (Appendix 4).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dutasteride	Dutasteride	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52	Baseline and Week 52	The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Qmax Improvement From Baseline at Week 52	Baseline and Week 52	Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec
Percent Change From Baseline in Prostate Volume at Week 52	Baseline and Week 52	Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.
Number of Participants With IPSS Improvement From Baseline at Week 52	Baseline and Week 52	Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.
Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52	Baseline and Week 52	Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.