Trial Outcomes & Findings for A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia (NCT NCT00793819)
NCT ID: NCT00793819
Last Updated: 2012-03-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
215 participants
Primary outcome timeframe
12 weeks
Results posted on
2012-03-09
Participant Flow
Participant milestones
| Measure |
Silodosin 8mg
Silodosin 8mg daily
|
Placebo
1 placebo capsule daily
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
98
|
|
Overall Study
COMPLETED
|
97
|
89
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
Reasons for withdrawal
| Measure |
Silodosin 8mg
Silodosin 8mg daily
|
Placebo
1 placebo capsule daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Silodosin 8mg
n=111 Participants
Silodosin 8mg daily
|
Placebo
n=98 Participants
1 placebo capsule daily
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age Continuous
|
64.6 years
STANDARD_DEVIATION 8.03 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 8.92 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 8.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
98 participants
n=7 Participants
|
209 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
Outcome measures
| Measure |
Silodosin 8mg
n=112 Participants
Silodosin 8mg daily
|
Placebo
n=97 Participants
1 placebo capsule daily
|
|---|---|---|
|
Change in Nocturia Episodes
|
-1.2 episodes
Standard Deviation 1.35
|
-1.0 episodes
Standard Deviation 1.44
|
Adverse Events
Silodosin 8mg
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Silodosin 8mg
n=111 participants at risk
Silodosin 8mg daily
|
Placebo
n=98 participants at risk
1 placebo capsule daily
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.90%
1/111 • Number of events 1 • 12 weeks
|
0.00%
0/98 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Multiple Bone Fracture
|
0.00%
0/111 • 12 weeks
|
1.0%
1/98 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Silodosin 8mg
n=111 participants at risk
Silodosin 8mg daily
|
Placebo
n=98 participants at risk
1 placebo capsule daily
|
|---|---|---|
|
Reproductive system and breast disorders
Retrograde Ejaculation
|
21.6%
24/111 • Number of events 24 • 12 weeks
|
0.00%
0/98 • 12 weeks
|
|
Nervous system disorders
Headache
|
4.5%
5/111 • Number of events 5 • 12 weeks
|
1.0%
1/98 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.6%
4/111 • Number of events 4 • 12 weeks
|
3.1%
3/98 • Number of events 3 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
3.6%
4/111 • Number of events 5 • 12 weeks
|
3.1%
3/98 • Number of events 4 • 12 weeks
|
|
General disorders
Fatigue
|
3.6%
4/111 • Number of events 4 • 12 weeks
|
1.0%
1/98 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
3/111 • Number of events 3 • 12 weeks
|
4.1%
4/98 • Number of events 4 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.7%
3/111 • Number of events 3 • 12 weeks
|
0.00%
0/98 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
1.8%
2/111 • Number of events 2 • 12 weeks
|
5.1%
5/98 • Number of events 5 • 12 weeks
|
|
Infections and infestations
Urinary Track Infection
|
0.00%
0/111 • 12 weeks
|
3.1%
3/98 • Number of events 3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.8%
2/111 • Number of events 2 • 12 weeks
|
2.0%
2/98 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Upper Respiratory Track Infection
|
1.8%
2/111 • Number of events 2 • 12 weeks
|
2.0%
2/98 • Number of events 2 • 12 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/111 • 12 weeks
|
2.0%
2/98 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/111 • 12 weeks
|
2.0%
2/98 • Number of events 2 • 12 weeks
|
Additional Information
Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
Watson Pharmaceuticals
Phone: 801-588-6641
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60