Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00368979
First received: August 24, 2006
Last updated: April 17, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Prostatic Hyperplasia
Drug: Dutasteride
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Dutasteride in Benign Prostatic Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 (Dutasteride) in Subjects With Benign Prostatic Hyperplasia.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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:
  • Percent Change From Baseline in Prostate Volume at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.

  • Number of Participants With Qmax Improvement From Baseline at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec


Enrollment: 378
Study Start Date: February 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dutasteride Drug: Dutasteride
once daily
Placebo Comparator: Placebo Drug: Placebo
once daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368979

Locations
Japan
GSK Investigational Site
Chiba, Japan, 272-0107
GSK Investigational Site
Chiba, Japan, 266-0031
GSK Investigational Site
Chiba, Japan, 263-0043
GSK Investigational Site
Fukuoka, Japan, 802-0077
GSK Investigational Site
Fukuoka, Japan, 830-0027
GSK Investigational Site
Fukuoka, Japan, 810-0001
GSK Investigational Site
Hyogo, Japan, 660-0052
GSK Investigational Site
Kanagawa, Japan, 259-1132
GSK Investigational Site
Kanagawa, Japan, 229-1103
GSK Investigational Site
Kanagawa, Japan, 215-0021
GSK Investigational Site
Kanagawa, Japan, 252-0804
GSK Investigational Site
Kanagawa, Japan, 226-0025
GSK Investigational Site
Kanagawa, Japan, 245-0015
GSK Investigational Site
Kyoto, Japan, 604-8436
GSK Investigational Site
Oita, Japan, 874-0937
GSK Investigational Site
Oita, Japan, 871-0012
GSK Investigational Site
Osaka, Japan, 542-0073
GSK Investigational Site
Osaka, Japan, 562-0036
GSK Investigational Site
Osaka, Japan, 584-0074
GSK Investigational Site
Tokyo, Japan, 152-0001
GSK Investigational Site
Tokyo, Japan, 153-0051
GSK Investigational Site
Tokyo, Japan, 186-0011
GSK Investigational Site
Tokyo, Japan, 183-0044
GSK Investigational Site
Tokyo, Japan, 150-0002
GSK Investigational Site
Tokyo, Japan, 131-0032
GSK Investigational Site
Tokyo, Japan, 130-0026
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00368979     History of Changes
Other Study ID Numbers: ARI105326
Study First Received: August 24, 2006
Results First Received: December 5, 2008
Last Updated: April 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Benign Prostatic Hyperplasia BPH dutasteride

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014