Last updated: 11/07/2018 08:17:04
Safety and efficacy of 0.5mg dutasteride and 0.4mg tamsulosin combination once daily for six months for benign prostatic hyperplasiaFDC114785
GSK study ID
114785
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with any on-treatment adverse events (AEs) or any serious adverse event (SAEs) and treatment-related AEs
Timeframe: From start of study medication until follow-up (up to 7 months)
Number of participants with any post-treatment adverse events (AEs) or any serious adverse event (SAEs) and treatment-related AEs
Timeframe: From start of study medication until follow-up (up to 7 months)
Number of participants with abnormal electrocardiogram (ECG) findings at the indicated time points
Timeframe: Screening, Month 1, Month 3 and Month 6
Number of participants with clinical chemistry values shift from normal at Baseline to abnormal at any time post-Baseline
Timeframe: Screening, Month 1, Month 3 and Month 6
Number of participants with hematology values shift from normal at Baseline to abnormal at any time post-Baseline
Timeframe: Screening, Month 3 and Month 6
Number participants with a negative or positive response at the indicated time points
Timeframe: Screening, Month 3 and Month 6
Change from Baseline in total prostate -specific antigen (PSA) at the indicated time points
Timeframe: Baseline, Month 3 and Month 6
Free to total PSA ratio at the indicated time points
Timeframe: Baseline, Month 6
Secondary outcomes:
Change from Baseline in the international prostate symptom score (IPSS) at Month 6
Timeframe: Baseline and Month 6
Change from Baseline in maximum rate of urinary flow (Qmax) at the indicated time points
Timeframe: Baseline, Month 3 and Month 6
Interventions:
Enrollment:
59
Primary completion date:
2015-20-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
June 2012 to March 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
No
- Male, age ≥ 50 years.
- Clinical diagnosis of benign prostate hypertrophy (BPH) .
- 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.
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2015-20-03
Actual study completion date
2015-20-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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