Dutasteride With Tolterodine ER or Placebo to Treat Lower... | NCT00939120

NCT00939120

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
GlaxoSmithKline	INDUSTRY
Pfizer	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tolterodine ER 4mg	Experimental	1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily	Drug: Tolterodine ER 4mg Drug: Pre-randomization Dutasteride
placebo	Placebo Comparator	1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily	Drug: Placebo Drug: Pre-randomization Dutasteride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tolterodine ER 4mg	Drug	1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-void Residual (PVR) Volume	To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.	12 months
Maximum Urine Flow Rate (Qmax).	To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.	12 months
Urine Voided Volume (Voiding)	To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.	12 months
Acute Urinary Retention (AUR)	To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Overactive Bladder Questionnaire (OABq)	To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This subject population will consist of males ≥ 50 years of age who have lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) for a minimum of 3 months

Inclusion criteria at screening:

Subjects who understand and speak English and are able to comply with the protocol, complete the diaries, and other study tools
Subject has provided written informed consent and HIPAA authorization
Ambulatory male subjects ≥ 50 years of age
Able to use the toilet without difficulty
History of LUTS due to BPE, as diagnosed by history as well as digital rectal exam (DRE), for ≥ 3 months suitable for medical therapy with 5-ARI in combination with antimuscarinic drugs
Prostate volume (PV) ≥ 30 cc as measured by transrectal ultrasound (TRUS)
International prostate symptoms score (IPSS) ≥12
Post Void Residual Volume < 150 mL at baseline
Uroflowmetry-Qmax > 5 mL/sec and ≤ 15 mL/sec
Prostate specific antigen (PSA) ≥ 1.5 ng/ml and in normal age-adjusted range. For those subjects with an elevated age-adjusted PSA, it is the responsibility of the investigator to take standard of care measures to assure reasonable absence of prostate cancer
Have an average of ≥ 8 micturitions per 24 hrs
Have an average of 2 episodes of urgency per 24 hrs (defined as those with the Urinary Sensation Scale rating of 3 or more)

Exclusion Criteria:

Concurrent use of 5-ARI therapy within the past 3 months
Concurrent use of alpha blockers within the past 2 weeks
Concurrent use of antimuscarinics within the past 4 weeks
Concurrent use of Phosphodiesterase type 5 (PDE-5) inhibitors on a daily basis
Evidence of chronic inflammation such as interstitial cystitis and bladder stones.
Evidence of untreated urethral stricture disease
Uncontrolled narrow angle glaucoma
Increased post-void residual volume (PVR) defined as PVR > 150 mL
Uroflowmetry-Qmax ≤ 5 mL/sec
Acute urinary tract infection (UTI). These subjects may be treated and re-screened
Acute urinary retention (AUR) requiring catheter within the last 3 months
Previous or planned transurethral resection of the prostate (TURP)
Minimally invasive surgery (MIS) such as transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other minimally invasive procedures within 12 months. Those patients who in the opinion of the investigator did not respond adequately to MIS and fulfill the inclusion criteria are eligible to participate
A known diagnosis of prostate cancer.
A known diagnosis of bladder cancer within 5 years of screening. Those patients with history of non-muscle invasive bladder cancer who have not had a recurrence in the past 5 years are eligible to screen for this study and must maintain continued adequate bladder cancer screening at the discretion of the Investigator
Renal or hepatic impairment defined as 2.5 x upper limit of normal. Some isolated abnormalities would be left at the discretion of the investigator with always keeping in mind to not pose a hazard to the patient.
PSA > 10 ng/mL (if the PSA is greater than 4 ng/mL and less than or equal to 10 ng/mL, subjects may be included at the discretion of the Investigator if the PSA has been stable and the patient has had a prostate biopsy showing no evidence of prostate cancer)
Known or suspected hypersensitivity to dutasteride or tolterodine ER .
Participation in a clinical trial involving an investigational drug, within 30 days prior to enrollment.
History of diagnosed gastrointestinal obstruction disease.
Myocardial infarction within the past 8 weeks.
Known or suspected drug and/or alcohol abuse.
Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.

Name	Affiliation	Role
Paul F Siami, MD	Deaconess Clinic Research Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Deaconess Clinic Gateway Health Center		Newburgh	Indiana	47630	United States

ID	Title	Description
FG000	Tolterodine ER 4mg + Dutasteride 0.5mg	Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
FG001	Placebo + Dutasteride 0.5mg	Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.

ID	Title	Description
BG000	Tolterodine ER 4mg + Dutasteride 0.5mg	Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
BG001	Placebo + Dutasteride 0.5mg

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous	Age of patient at enrollment

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Post-void Residual (PVR) Volume

To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.

Last data point carried forward for participants who were randomized and dropped prior to study end.

Posted

Mean

Standard Error

12 months

ID	Title	Description
OG000	Tolterodine ER 4mg + Dutasteride 0.5mg	Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
OG001	Placebo + Dutasteride 0.5mg	Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tolterodine ER 4mg + Dutasteride 0.5mg	Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D010665	Phenylpropanolamine
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols