Clinical Trials Logo
  1. Home
  2. Prostatic Hyperplasia
  3. NCT00793819
  4. Details
NCT00793819 Clinical Trial

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Prostatic Hyperplasia Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00793819
Other study ID # SI08005
Secondary ID
Status Completed
Phase Phase 2
First received November 17, 2008
Last updated February 7, 2012
Start date January 2009
Est. completion date October 2009

Study information
Verified date February 2012
Source Watson Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Description:

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Recruitment information / eligibility
Status Completed
Enrollment 215
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH and nocturia (>=2 episodes per night)

Exclusion Criteria:

- Medical conditions that would confound the efficacy evaluation.

- Medical conditions in which it would be unsafe to use an alpha-blocker.

- The use of concomitant drugs that would confound the efficacy evaluation.

- The use of concomitant drugs that would be unsafe with this alpha-blocker.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• silodosin
a1-adrenergic antagonist

Locations
Country Name City State
United States Watson Investigational Site Albuquerque New Mexico
United States Watson Investigational Site Aventura Florida
United States Watson Investigational Site Bala Cynwyd Pennsylvania
United States Watson Investigational Site Bay Shore New York
United States Watson Investigational Site Bethany Oklahoma
United States Watson Investigational Site Burien Washington
United States Watson Investigational Site Clearwater Florida
United States Watson Investigational Site Coeur d'Alene Idaho
United States Watson Investigational Site Concord North Carolina
United States Watson Investigational Site Greenbelt Maryland
United States Watson Investigational Site Huntsville Alabama
United States Watson Investigational Site Laguna Hills California
United States Watson Investigational Site Las Vegas Nevada
United States Watson Investigational Site Lawrenceville New Jersey
United States Watson Investigational Site Marietta Georgia
United States Watson Investigational Site Missoula Montana
United States Watson Investigational Site Myrtle Beach South Carolina
United States Watson Investigational Site New York New York
United States Watson Investigational Site Omaha Nebraska
United States Watson Investigational Site Orlando Florida
United States Watson Investigational Site Paducah Kentucky
United States Watson Investigational Site Salisbury North Carolina
United States Watson Investigational Site San Diego California
United States Watson Investigational Site Sandy Springs Georgia
United States Watson Investigational Site Troy Michigan
United States Watson Investigational Site West Des Moines Iowa
United States Watson Investigational Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Nocturia Episodes 12 weeks No
See also
  Status Clinical Trial Phase
Completed NCT02578953 - Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects Phase 1
Terminated NCT02396420 - Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams Phase 2
Terminated NCT04398966 - Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia N/A
Not yet recruiting NCT06452927 - EEP in Patients With Urodynamically Proven DU/DA N/A
Completed NCT02947958 - Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia N/A
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT00427882 - Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study Phase 4
Completed NCT02244320 - Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin) N/A
Completed NCT01254071 - A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. Phase 1
Recruiting NCT04108871 - Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men N/A
Recruiting NCT05686525 - Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH N/A
Completed NCT01957189 - This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples Phase 1
Completed NCT00316732 - Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS N/A
Completed NCT02715401 - PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers Phase 1
Recruiting NCT02278679 - Digital Rectal Exam Proficiency Tool N/A
Completed NCT01482676 - The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction N/A
Completed NCT01376258 - Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database N/A
Completed NCT00822952 - Prostate Mechanical Imager (PMI) Clinical Bridging Study N/A
Completed NCT00527605 - Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Terminated NCT00563485 - Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A