Benign prostatic hyperplasia MedDRA version: 14.0 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Duodart
Product Name: Duodart
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DUTASTERIDE
CAS Number: 164656-23-9
Other descriptive name: DUTASTERIDE
Concentration unit: mg milligr
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged =50 years. 2. A confirmed clinical diagnosis of BPH. 3. International Prostate Symptom Score (IPSS) 8-19 at Visit 1 (screening). 4. Prostate volume =30 cc (by transrectal ultrasonography; TRUS). 5. Total serum prostate specific antigen (PSA) =1.5 ng/mL at Visit 1 (screening). 6. Willing and able to give signed written informed consent and comply with study procedures. 7. Fluent and literate in local language with the ability to read, comprehend and record information on the IPSS and BII questionnaires. 8. Able to swallow and retain oral medication. 9. Willing and able to participate in the study for the full 2 years. 10. Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 halflives for the drug plus 3 months to allow clearance of any altered sperm after the last dose of study treatment. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 740 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Total serum PSA >10.0 ng/mL at Visit 1 (screening). 2. History or evidence of prostate cancer (e.g. positive biopsy or ultrasound within the previous 6 months, suspicious DRE and/or rising PSA). Excluded medication and therapies 3. Current or any prior use of the following prohibited medications i. a 5a-reductase inhibitor (finasteride or dutasteride), ii. anti-cholinergics (e.g. oxybutynin, propantheline) iii. an alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) for BPH or LUTS. iv. any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the previous 6 months. v. any drugs noted for gynaecomastia effects, or could affect prostate volume, within 6 months of the Visit 1 vi. any investigational or marketed study drug within 30 days or 5 half-lives, (whichever is longer), preceding the first dose of study treatment. 4. Current use of: i. any alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) ii. anabolic steroids. iii. drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin. 5. Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study. 6. Have a known (immediate or delayed) hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study medication or excipients that, in the opinion of the Investigator or GSK contraindicates their participation. Exceptions for this exclusion criteria 3 – 6 are: Topical use is permitted (e.g. cream, eye drops, etc ) or any systemic use NOT related to BPH and that has finished more than 7 months ago to ensure that in any case the time since last administration is longer than 7 half-lives Recent Medical Procedures 7. Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive or minimally invasive procedures to treat BPH. 8. History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (250 mL (suprapubic ultrasound) at Visit 1 (screening). 11. Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections). 12. History of ‘first dose’ hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy for hypertension. 13. History of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury. 14. History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy. 15. History of hepatic impairment or abnormal liver function tests at Visit 1 (screening). (defined as ALT, AST or alkaline phosphatase >2 times the ULN, or total bilirubin >1.5 times the ULN (unless associated with predominantly indirect bilirubin elevation or Gilbert's syn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of DUODART treatment plus lifestyle advice in providing superior symptomatic improvement to treatment naïve BPH subjects compared with watchful waiting plus lifestyle advice plus step-up therapy with tamsulosin.;Secondary Objective: To assess the efficacy of DUODART treatment plus lifestyle advice compared with watchful waiting plus lifestyle advice plus step-up therapy with tamsulosin for the following: • in providing superior improvement in BPH Impact Index (BII) score to BPH subjects • in providing superior improvement in BPH-related Health Status (BHS) to BPH subjects • in reducing clinical progression in BPH subjects • in reducing BPH-related prostatic surgery in BPH subjects. • in providing superior improvements in question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire • in providing superior improvements in question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire • Proportion of subjects with IPSS improvement of =2 points and =3 points from baseline and, separately, =25% improvement from baseline • To assess the safety and tolerability of DUODART. ;Primary end point(s): Lower urinary tract symptoms, which is defined as change in IPSS from baseline to Month 24.;Timepoint(s) of evaluation of this end point: Month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in BPH Impact Index score from baseline. Change in BPH-related Health Status (BHS) from baseline. Time to/proportion of subjects with Clinical progression of BPH. ;Timepoint(s) of evaluation of this end point: Month 24 | — |
Countries
France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom
Contacts
Public ContactGSK Clinical Support Helpdesk
GlaxoSmithKline
Outcome results
None listed