Study to Evaluate the Clinical Efficacy and Safety of Tam... | NCT02715024

Studies
Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms

NCT02715024

Sponsor

Astellas Pharma Taiwan, Inc.

Status

Completed

Last Update Posted

Mar 22, 2016Estimated

Enrollment

52Actual

Phase

Phase 4

Conditions

Lower Urinary Tract Symptoms
Overactive Bladder
Benign Prostatic Hyperplasia (BPH)

Interventions

Tamsulosin
Solifenacin

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Mar 17, 2016

First Submission Date that Met QC Criteria

Mar 17, 2016

First Posted Date

Mar 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2016

Last Update Posted Date

Mar 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Label	Type	Description	Intervention Names
Tamsulosin alone	Experimental		Drug: Tamsulosin
Tamsulosin + solifenacin	Experimental		Drug: Tamsulosin Drug: Solifenacin

Name	Type	Description	Arm Group Labels	Other Names
Tamsulosin	Drug	Oral	Tamsulosin + solifenacin Tamsulosin alone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment		Baseline and end of treatment (up to 12 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Change in mean number of urgency episode per 24 hours from baseline to the end of treatment		Baseline and end of treatment (up to 12 weeks)
Change in mean number of micturitions per 24 hours from baseline to the end of treatment		Baseline and end of treatment (up to 12 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months
I-PSS(S) score of ≥ 12
Maximum flow rate (Qmax) of 4 to15 mL/sec
Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
Benign digital rectal examination (DRE) result

Exclusion Criteria:

Clinically significant outflow obstruction
Significant post void residue volume (PVR >100ml)
Prostate specific antigen (PSA) ≥10 ng/mL
Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
Patient with a neurological cause for abnormal detrusor activity
Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum
Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
Patients with any other complication which may cause voiding dysfunction
Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
Patients receiving any medication therapy for LUTS/BPH 2 weeks prior to the study
Use of drugs to treat incontinence currently
Hypersensitivity to tamsulosin and/or solifenacin or to any component of the formulation
Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
Patients had taken any investigational drug in the previous 3 months prior to this study

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Therapeutic Area Lead of Medical Affairs (Asia-Oceania)	Astellas Pharma Taiwan, Inc.	Study Director

ID	Term
D059411	Lower Urinary Tract Symptoms
D053201	Urinary Bladder, Overactive
D011470	Prostatic Hyperplasia

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases

ID	Term
D000077409	Tamsulosin
D000069464	Solifenacin Succinate

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D006571	Heterocyclic Compounds
D044005	Tetrahydroisoquinolines
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring