Status:
COMPLETED
Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 17 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2007
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT00368979
Start Date
February 17 2006
End Date
December 6 2007
Last Update
September 26 2018
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Chiba, Japan, 263-0043
2
GSK Investigational Site
Chiba, Japan, 266-0031
3
GSK Investigational Site
Chiba, Japan, 272-0107
4
GSK Investigational Site
Fukuoka, Japan, 802-0077