Trial record 4 of 73 for:    Open Studies | "Prostatic Hyperplasia"

Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia (FDC114785)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01673490
First received: June 28, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Prostatic Hyperplasia
Drug: Dutasteride/Tamsulosin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Use the number of participants with adverse events,serious adverse events and treatment-related adverse events as a measure of Safety [ Time Frame: 6 months treatment and 1 month follow up ] [ Designated as safety issue: Yes ]
    Using the category,frequency and severity of adverse events,serious adverse events and treatment-related adverse events including abnormalities in heamatology,biochemistry,electrolytes,PSA and ECG encountered during the treatment period.


Secondary Outcome Measures:
  • Use changes in International Prostate symptom score (IPSS) and Qmax (Maximum rate of Urinary Flow (ml/sec) as a measure of Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    expect to see a decrease in IPSS and an increase Qmax compared to baseline visit


Estimated Enrollment: 90
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combodart/Duodart
Single arm testing the efficacy/safety of the combinnation of Dutasteride/Tamsulosin
Drug: Dutasteride/Tamsulosin
0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment
Other Names:
  • Duodart
  • combodart

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  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: NCT01673490

Contacts
Contact: US GSK Clinical Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Vietnam
GSK Investigational Site Recruiting
Ho Chi Minh, Vietnam
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01673490     History of Changes
Other Study ID Numbers: 114785
Study First Received: June 28, 2012
Last Updated: March 27, 2014
Health Authority: Vietnam: Ministry of Health

Keywords provided by GlaxoSmithKline:
Benign Prostatic Hyperplasia
dutasteride and tamsulosin

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Dutasteride
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses
5-alpha Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014