Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Hyperplasia
Intervention: Dutasteride/Tamsulosin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90
subjects will be enrolled so that among them at least 57 will complete the 6-month treatment
period and evaluable for analysis.
- Primary objective: To assess the safety of 0. 5 mg dutasteride/0. 4 mg tamsulosin combination
therapy for six month in BPH patients by monitoring category, frequency and severity of
adverse events encountered during the treatment period.
- Secondary objective: To assess the efficacy of 0. 5 mg dutasteride/0. 4 mg tamsulosin
combination therapy with regard to symptom improvement in BPH patients by monitoring and
analyzing of changes in IPSS and Qmax after 6 months of treatment.
Clinical Details
Official title: A Pivotal, Open-label Trial Assessing the Safety and Efficacy of the 0.5 mg Dutasteride and 0.4 mg Tamsulosin Combination Once Daily for Six Months in Patients With Benign Prostatic Hyperplasia
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Use the number of participants with adverse events,serious adverse events and treatment-related adverse events as a measure of Safety
Secondary outcome: Use changes in International Prostate symptom score (IPSS) and Qmax (Maximum rate of Urinary Flow (ml/sec) as a measure of Efficacy
Detailed description:
Visit 0 or Screening Visit (M0) - D0 + 2): Following tasks will be performed: ICF
collection, subject code assignment, physical examination (vital signs, demographic data,
medical history); checking of inclusion and exclusion criteria: prostate symptom score
according to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, total PSA
level, free-to-total PSA ratio, Qmax, urinalysis, transrectal prostate ultrasonography
(TRUS), 12-lead electrocardiography (ECG), scoring of Sexual Function Questionnaire (SFQ),
concomitant medication assessment, IP dispensing. • Visit 1 (Month 1 (M1) - D30 ± 3):
Following items will be recorded: treatment compliance, vital signs, blood chemistry, ECG,
adverse events (AEs), concomitant medication; dispensing of new IP doses and collecting of
dispensed IP at the last visit. • Visit 2 (Month 2 (M2) - D60 ± 3): Following items will be
recorded: treatment compliance, AEs, concomitant medication; dispensing of new IP doses and
collecting of dispensed IP at the last visit. • Visit 3 (Month 3 (M3) - D90 ± 3): Following
items will be recorded: vital signs, laboratory tests (hematology, blood chemistry,
electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level), concomitant medication, SFQ
score, AE assessment, collecting of dispensed IP at the last visit and dispensing of new IP
doses. • Visit 4 (Month 4. 5 (M4) - D135 ± 3): Following items will be recorded: treatment
compliance, vital signs, AEs, concomitant medication; dispensing of new IP doses and
collecting of dispensed IP at the last visit. Visit 5 (Month 6 (M6)- D180 ± 3): Following
items will be recorded: treatment compliance, vital signs, prostate symptom score according
to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis,
12-lead ECG, total PSA level, free-to-total PSA ratio, TRUS; concomitant medication, SFQ
score, AE assessment, collecting of the previous dispensed IPs . Follow-up Phone Call (Month
7 (M7)- D210 ± 3): To record any possible AE that may occur after discontinuation of study
treatment.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
Male, age ≥ 50 years. Clinical diagnosis of benign prostate hypertrophy (BPH) .
International Prostate Symptom Score (IPSS) ≥ 12 Prostate volume ≥30 ml (transrectal
ultrasonography). Total serum prostate specific antigen (PSA) ≥1. 5 ng/mL and ≤10 ng/mL.
Free-to-total PSA ratio > 20% Maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and
post-void residual volume of < 150 mL Willing and able to give written informed consent
and comply with study procedures throughout study Able to swallow and retain oral
medication Able to express personal thought and feeling Ability to read and comprehend
information on the Sexual Function Inventory
Exclusion Criteria:
History or evidence of prostate cancer (e. g. positive biopsy or ultrasound, suspicious
digital rectal examination).
Previous prostatic surgery (TURP, balloon dilatation, thermotherapy and stent replacement)
or other invasive procedures to treat BPH.
History of flexible/rigid cystoscopy or other instrumentation of the urethra within past 7
days History of acute urine retention (AUR) within past 3 months. Any causes other than
BPH result in urinary symptoms or changes in flow rate (e. g. neurogenic bladder, bladder
neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis,
acute or chronic urinary tract infections).
History of breast cancer or clinical finding suggestive of malignancy. Use of any
5-alpha-reductase inhibitor (e. g. Proscar®, Propecia®), drugs with antiandrogenic
properties (e. g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole,
progestational agents), drugs which induce gynecomastia or drugs which affect prostate
volume, within past 6 months and throughout the study (other than as study medication). Do
not use dutasteride within past 12 months. Do not use metronidazole for a long time.
Concurrent use of anabolic steroids (eg. Durabolin®). Use of phytotherapy (eg: Tadenan®,
Permixon®, etc) for BPH within 2 weeks of screening visit and/or predicted to need
phytotherapy during the study.
Use of any alpha-adrenoreceptor blockers (i. e. indoramin, prazosin, terazosin, tamsulosin,
alfuzosin and doxazosin) within 2 weeks of screening visit and/or predicted to need any
alpha blockers other than tamsulosin during the study.
Use of any alpha-adrenoreceptor agonists (e. g. pseudoephedrine, phenylephrine, ephedrine)
or anticholinergics (e. g. oxybutynin, propantheline) or cholinergics (e. g. bethanecol
chloride) within 48 hours prior to all uroflowmetry assessments.
Hypersensitivity to any alpha-/beta-adrenoreceptor blocker or 5-alpha-reductase inhibitor,
or other chemically-related drugs.
Concurrent use of drugs known or thought to have an interaction with tamsulosin and
dutasteride.
History of hepatic impairment or abnormal liver function tests at screening (defined ALT,
AST, and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin
>1. 5 times the upper limit of normal).
History of renal insufficiency, or serum creatinine >1. 5 times the upper limit of normal
at screening.
History of malignancies other than basal cell carcinoma or squamous cell carcinoma of the
skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of
disease for at least 5 years prior to screening are eligible.
Any unstable, serious co-existing medical condition(s) including, but not limited to,
myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias,
clinically evident congestive heart failure, or cerebrovascular accident within past 6
months; medically uncontrollable diabetes or peptic ulcer disease History of postural
hypotension, dizziness, vertigo or any signs and symptoms of orthostasis, which in
judgments of investigator, could be exacerbated by tamsulosin History of unsuccessful
treatment with tamsulosin or 'first dose' hypotensive episode on initiation of
alpha-1-adrenoreceptor antagonist therapy.
History of unsuccessful treatment with finasteride or dutasteride. Willing to have a child
during the treatment period or within 6 months thereafter Having female partner who is a
pregnant woman or in child-bearing age and refuse to use condom for sexual protection
Willing to donate blood during treatment period or within 6 months thereafter. History or
current evidence of drug or alcohol abuse within past 12 months. History of any illness
might confound the results of the study or poses additional risk to the patient.
Participation in investigational or marketed drug trial within 30 days preceding the
screening visit and/or during the study treatment
Locations and Contacts
GSK Investigational Site, Ho Chi Minh, Vietnam
Additional Information
Starting date: June 2012
Last updated: July 20, 2015
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