Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

NCT00368979 | Completed Phase 3 Results

• 1 other identifier: ARI105326
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 26

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.

Conditions

Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia BPH dutasteride

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in International Prostate Symptom Score (IPSS) at 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.

  Baseline and Week 52

Secondary Outcomes (4)

• Percent Change From Baseline in Prostate Volume at Week 52

  Baseline and Week 52

• Number of Participants With IPSS Improvement From Baseline at Week 52

  Baseline and Week 52

• Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52

  Baseline and Week 52

• Number of Participants With Qmax Improvement From Baseline at Week 52

  Baseline and Week 52

Study Arms (2)

Dutasteride

ACTIVE COMPARATOR

Drug: Dutasteride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dutasteride DRUG

once daily

Dutasteride

Placebo DRUG

once daily

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (26)

GSK Investigational Site

Chiba, 263-0043, Japan

Location

GSK Investigational Site

Chiba, 266-0031, Japan

Location

GSK Investigational Site

Chiba, 272-0107, Japan

Location

GSK Investigational Site

Fukuoka, 802-0077, Japan

Location

GSK Investigational Site

Fukuoka, 810-0001, Japan

Location

GSK Investigational Site

Fukuoka, 830-0027, Japan

Location

GSK Investigational Site

Hyōgo, 660-0052, Japan

Location

GSK Investigational Site

Kanagawa, 215-0021, Japan

Location

GSK Investigational Site

Kanagawa, 226-0025, Japan

Location

GSK Investigational Site

Kanagawa, 229-1103, Japan

Location

GSK Investigational Site

Kanagawa, 245-0015, Japan

Location

GSK Investigational Site

Kanagawa, 252-0804, Japan

Location

GSK Investigational Site

Kanagawa, 259-1132, Japan

Location

GSK Investigational Site

Kyoto, 604-8436, Japan

Location

GSK Investigational Site

Osaka, 542-0073, Japan

Location

GSK Investigational Site

Osaka, 562-0036, Japan

Location

GSK Investigational Site

Osaka, 584-0074, Japan

Location

GSK Investigational Site

Ōita, 871-0012, Japan

Location

GSK Investigational Site

Ōita, 874-0937, Japan

Location

GSK Investigational Site

Tokyo, 130-0026, Japan

Location

GSK Investigational Site

Tokyo, 131-0032, Japan

Location

GSK Investigational Site

Tokyo, 150-0002, Japan

Location

GSK Investigational Site

Tokyo, 152-0001, Japan

Location

GSK Investigational Site

Tokyo, 153-0051, Japan

Location

GSK Investigational Site

Tokyo, 183-0044, Japan

Location

GSK Investigational Site

Tokyo, 186-0011, Japan

Location

Related Publications (1)

• Tsukamoto T, Endo Y, Narita M. Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia. Int J Urol. 2009 Sep;16(9):745-50. doi: 10.1111/j.1442-2042.2009.02357.x. Epub 2009 Aug 5.

  PMID: 19674165 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: February 17, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 6, 2007
• Last Updated: September 26, 2018
• Results First Posted: April 2, 2009

Record last verified: 2018-08

Locations

JP (26)