A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

This study has been completed.

Sponsor:

Information provided by:

Watson Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00224107

First received: September 14, 2005

Last updated: July 5, 2011

Last verified: July 2011

History of Changes

Results First Received: September 8, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Benign Prostatic Hyperplasia (BPH)
Interventions:	Drug: Silodosin Other: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Silodosin	Silodosin 8 mg once daily with food
Placebo	Matching placebo capsule once daily with food

Participant Flow: Overall Study

	Silodosin	Placebo
STARTED	233	228
COMPLETED	202	214
NOT COMPLETED	31	14
Adverse Event	20	6
Protocol Violation	2	3
Withdrawal by Subject	1	4
Lack of Efficacy	2	0
Lost to Follow-up	4	0
Physician Decision	1	0
Not specified	1	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Silodosin	Silodosin 8 mg once daily with food
Placebo	Matching placebo capsule once daily with food
Total	Total of all reporting groups

Baseline Measures

	Silodosin	Placebo	Total
Number of Participants [units: participants]	233	228	461
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	136	130	266
>=65 years	97	98	195
Age [units: years] Mean ± Standard Deviation	64.4 ± 7.94	64.0 ± 7.84	64.2 ± 7.88
Gender [units: participants]
Female	0	0	0
Male	233	228	461
Region of Enrollment [units: participants]
United States	233	228	461

Outcome Measures

Show All Outcome Measures

1. Primary:

International Prostate Symptom Score (IPSS) [ Time Frame: 12 weeks ]

Show Outcome Measure 1

2. Secondary:

Maximum Urine Flow Rate (Qmax) [ Time Frame: 12 weeks ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Gary Hoel, RPh, PhD, Executive Director of Clinical Research
Organization: Watson Laboratories, Inc.
phone: 801-588-6641
e-mail: gary.hoel@watson.com

Publications of Results:

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009 Jun;181(6):2634-40. Epub 2009 Apr 16.

Publications automatically indexed to this study:

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective α(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2013 Jan;189(1 Suppl):S122-8. doi: 10.1016/j.juro.2012.11.020.

Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011 Jun;14(2):143-8. Epub 2010 Dec 7.

Responsible Party:	Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00224107 History of Changes
Other Study ID Numbers:	SI04009
Study First Received:	September 14, 2005
Results First Received:	September 8, 2009
Last Updated:	July 5, 2011
Health Authority:	United States: Food and Drug Administration

To Top