Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: Dutasteride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

This study will assess the efficacy and safety of GI198745 0. 5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.

Official title: Clinical Evaluation of GI198745 in Benign Prostatic Hyperplasia- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 in Patients With Benign Prostatic Hyperplasia

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in IPSS at week 52

Secondary outcome:

Percent change from baseline in prostate volume Proportion of subjects with IPSS improvement Change from baseline in peak urinary flow (Qmax) Proportion of subjects with Qmax improvement

·Percent change from baseline in prostate volume ·Proportion of subjects with I-PSS improvement (≥2 point, ≥3 point, ≥4 point, ≥5 point, and ≥6 point improvement, and ≥20%, ≥25%, ≥30%, ≥40%, ≥50%, and ≥75% improvement) ·Change from baseline in Qmax

·Proportion of subjects with Qmax improvement (≥1mL/sec, ≥2mL/sec, ≥2.5mL/sec, ≥3mL/sec, ≥4mL/sec, 5mL/sec and ≥10mL/sec improvement, and ≥30% improvement)

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

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

1. Diagnosis: BPH

2. Age: ≥50 years

3. Gender: Male

4. Estimated prostate volume ≥30cc (by TRUS)

5. I-PSS Symptom Score (total of 7 items) ≥8 points

6. Maximum flow rate (Qmax) ≤15mL/sec (voided volume measured simultaneously ≤150mL)*[1]

7. 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.

8. Outpatients

9. 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.

1. Post void residual volume >250mL (by suprapubic ultrasound).

2. History of AUR within the previous 12 weeks.

3. Evidence or history of prostate cancer.

4. 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].

5. Previous surgery (including balloon dilatation, thermotherapy and stent placement) or minimally invasive techniques for BPH.

6. 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).

7. 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.

8. Liver function tests (AST, ALT, AL-P) >2 times the upper limit of normal.

9. Serum cleatinine >1. 8mg/dL.

10. Use of any antiandrogen (e. g., chlormadinone acetate, allylesterenol) for BPH within the previous 12 months.

11. 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).

GSK Clinical Trials Call Center, Beppu 874, Japan

GSK Clinical Trials Call Center, Kunitachi 186, Japan

GSK Clinical Trials Call Center, Ichikawa 272, Japan

GSK Clinical Trials Call Center, Sumida 132, Japan

GSK Clinical Trials Call Center, Fukuoka City 810, Japan

GSK Clinical Trials Call Center, Kitakyushu 537, Japan

GSK Clinical Trials Call Center, Kurume City 830, Japan

GSK Clinical Trials Call Center, Nakatsu 871, Japan

GSK Clinical Trials Call Center, Meguro 152, Japan

GSK Clinical Trials Call Center, Sumida 130, Japan

GSK Clinical Trials Call Center, Shibuya 150, Japan

GSK Clinical Trials Call Center, Fuchu 183, Japan

GSK Clinical Trials Call Center, Kawasaki 215, Japan

GSK Clinical Trials Call Center, Chiba City 263, Japan

GSK Clinical Trials Call Center, Fujisawa 252, Japan

GSK Clinical Trials Call Center, Chiba City 266, Japan

GSK Clinical Trials Call Center, Yokohama City 245, Japan

GSK Clinical Trials Call Center, Sagamihara City 229, Japan

GSK Clinical Trials Call Center, Isehara City 259, Japan

GSK Clinical Trials Call Center, Amagasaki 660, Japan

GSK Clinical Trials Call Center, Tondabayashi 584, Japan

GSK Clinical Trials Call Center, Minoo 562, Japan

GSK Clinical Trials Call Center, Meguro 153, Japan

GSK Clinical Trials Call Center, Osaka City 542, Japan

GSK Clinical Trials Call Center, Kyoto City 604, Japan

GSK Clinical Trials Call Center, Yokohama City 226, Japan

Starting date: January 2006
Ending date: December 2007
Last updated: June 9, 2008