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

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ClinicalTrials.gov Identifier: NCT00793819
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : March 9, 2012
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Nocturia
Prostatic Hyperplasia
Intervention Drug: silodosin
Enrollment 215
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Silodosin 8mg Placebo
Hide Arm/Group Description Silodosin 8mg daily 1 placebo capsule daily
Period Title: Overall Study
Started 111 98
Completed 97 89
Not Completed 14 9
Reason Not Completed
Adverse Event             8             4
Lack of Efficacy             1             1
Withdrawal by Subject             4             3
Lost to Follow-up             1             1
Arm/Group Title Silodosin 8mg Placebo Total
Hide Arm/Group Description Silodosin 8mg daily 1 placebo capsule daily Total of all reporting groups
Overall Number of Baseline Participants 111 98 209
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 98 participants 209 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
63
  56.8%
62
  63.3%
125
  59.8%
>=65 years
48
  43.2%
36
  36.7%
84
  40.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 98 participants 209 participants
64.6  (8.03) 64.2  (8.92) 64.4  (8.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 98 participants 209 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
111
 100.0%
98
 100.0%
209
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 98 participants 209 participants
111 98 209
1.Primary Outcome
Title Change in Nocturia Episodes
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
Arm/Group Title Silodosin 8mg Placebo
Hide Arm/Group Description:
Silodosin 8mg daily
1 placebo capsule daily
Overall Number of Participants Analyzed 112 97
Mean (Standard Deviation)
Unit of Measure: episodes
-1.2  (1.35) -1.0  (1.44)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Silodosin 8mg Placebo
Hide Arm/Group Description Silodosin 8mg daily 1 placebo capsule daily
All-Cause Mortality
Silodosin 8mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Silodosin 8mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/111 (0.90%)      1/98 (1.02%)    
Infections and infestations     
Cellulitis  1  1/111 (0.90%)  1 0/98 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Multiple Bone Fracture  1  0/111 (0.00%)  0 1/98 (1.02%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Silodosin 8mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/111 (35.14%)      21/98 (21.43%)    
Gastrointestinal disorders     
Diarrhoea  1  3/111 (2.70%)  3 4/98 (4.08%)  4
General disorders     
Fatigue  1  4/111 (3.60%)  4 1/98 (1.02%)  1
Infections and infestations     
Urinary Track Infection  1  0/111 (0.00%)  0 3/98 (3.06%)  3
Upper Respiratory Track Infection  1  2/111 (1.80%)  2 2/98 (2.04%)  2
Musculoskeletal and connective tissue disorders     
Back Pain  1  4/111 (3.60%)  4 3/98 (3.06%)  3
Musculoskeletal Pain  1  2/111 (1.80%)  2 2/98 (2.04%)  2
Nervous system disorders     
Headache  1  5/111 (4.50%)  5 1/98 (1.02%)  1
Dizziness  1  4/111 (3.60%)  5 3/98 (3.06%)  4
Psychiatric disorders     
Insomnia  1  2/111 (1.80%)  2 5/98 (5.10%)  5
Reproductive system and breast disorders     
Retrograde Ejaculation  1  24/111 (21.62%)  24 0/98 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion  1  3/111 (2.70%)  3 0/98 (0.00%)  0
Cough  1  0/111 (0.00%)  0 2/98 (2.04%)  2
Vascular disorders     
Hypertension  1  0/111 (0.00%)  0 2/98 (2.04%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
Organization: Watson Pharmaceuticals
Phone: 801-588-6641
EMail: gary.hoel@watson.com
Layout table for additonal information
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00793819    
Other Study ID Numbers: SI08005
First Submitted: November 17, 2008
First Posted: November 19, 2008
Results First Submitted: February 7, 2012
Results First Posted: March 9, 2012
Last Update Posted: March 9, 2012