Trial Outcomes & Findings for A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo (NCT NCT00224107)
NCT ID: NCT00224107
Last Updated: 2011-07-12
Results Overview
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
461 participants
Primary outcome timeframe
12 weeks
Results posted on
2011-07-12
Participant Flow
Participant milestones
| Measure |
Silodosin
Silodosin 8 mg once daily with food
|
Placebo
Matching placebo capsule once daily with food
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
228
|
|
Overall Study
COMPLETED
|
202
|
214
|
|
Overall Study
NOT COMPLETED
|
31
|
14
|
Reasons for withdrawal
| Measure |
Silodosin
Silodosin 8 mg once daily with food
|
Placebo
Matching placebo capsule once daily with food
|
|---|---|---|
|
Overall Study
Adverse Event
|
20
|
6
|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
Baseline characteristics by cohort
| Measure |
Silodosin
n=233 Participants
Silodosin 8 mg once daily with food
|
Placebo
n=228 Participants
Matching placebo capsule once daily with food
|
Total
n=461 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
136 Participants
n=93 Participants
|
130 Participants
n=4 Participants
|
266 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
97 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
195 Participants
n=27 Participants
|
|
Age Continuous
|
64.4 years
STANDARD_DEVIATION 7.94 • n=93 Participants
|
64.0 years
STANDARD_DEVIATION 7.84 • n=4 Participants
|
64.2 years
STANDARD_DEVIATION 7.88 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=93 Participants
|
228 Participants
n=4 Participants
|
461 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
233 participants
n=93 Participants
|
228 participants
n=4 Participants
|
461 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
Outcome measures
| Measure |
Silodosin
n=233 Participants
Silodosin 8 mg once daily with food
|
Placebo
n=228 Participants
Matching placebo capsule once daily with food
|
|---|---|---|
|
International Prostate Symptom Score (IPSS)
Baseline IPSS
|
21.5 Units on a 0 to 35 scale
Standard Deviation 5.38
|
21.4 Units on a 0 to 35 scale
Standard Deviation 4.91
|
|
International Prostate Symptom Score (IPSS)
Change from Baseline in IPSS at Week 12
|
-6.5 Units on a 0 to 35 scale
Standard Deviation 6.73
|
-3.6 Units on a 0 to 35 scale
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
Change from baseline in maximum urine flow rate (Qmax)at Week 12
Outcome measures
| Measure |
Silodosin
n=233 Participants
Silodosin 8 mg once daily with food
|
Placebo
n=228 Participants
Matching placebo capsule once daily with food
|
|---|---|---|
|
Maximum Urine Flow Rate (Qmax)
Baseline Qmax
|
9.0 mL/sec
Standard Deviation 2.60
|
9.0 mL/sec
Standard Deviation 2.85
|
|
Maximum Urine Flow Rate (Qmax)
Change from Baseline in Qmax at Week 12
|
2.2 mL/sec
Standard Deviation 4.31
|
1.2 mL/sec
Standard Deviation 3.81
|
Adverse Events
Silodosin
Serious events: 3 serious events
Other events: 116 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Silodosin
n=233 participants at risk
Silodosin 8 mg once daily with food
|
Placebo
n=228 participants at risk
Matching placebo capsule once daily with food
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.43%
1/233 • Number of events 1 • 12 weeks
|
0.00%
0/228 • 12 weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/233 • 12 weeks
|
0.44%
1/228 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/233 • 12 weeks
|
0.44%
1/228 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Enterococcal bacteremia
|
0.43%
1/233 • Number of events 1 • 12 weeks
|
0.00%
0/228 • 12 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.86%
2/233 • Number of events 2 • 12 weeks
|
0.44%
1/228 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
0.43%
1/233 • Number of events 1 • 12 weeks
|
0.00%
0/228 • 12 weeks
|
|
Nervous system disorders
Radiculopathy
|
0.43%
1/233 • Number of events 1 • 12 weeks
|
0.00%
0/228 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.43%
1/233 • Number of events 1 • 12 weeks
|
0.00%
0/228 • 12 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/233 • 12 weeks
|
0.44%
1/228 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Silodosin
n=233 participants at risk
Silodosin 8 mg once daily with food
|
Placebo
n=228 participants at risk
Matching placebo capsule once daily with food
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
7/233 • Number of events 8 • 12 weeks
|
0.44%
1/228 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
2.6%
6/233 • Number of events 6 • 12 weeks
|
1.8%
4/228 • Number of events 4 • 12 weeks
|
|
Nervous system disorders
Headache
|
3.4%
8/233 • Number of events 8 • 12 weeks
|
1.3%
3/228 • Number of events 4 • 12 weeks
|
|
Nervous system disorders
Insomnia
|
2.1%
5/233 • Number of events 5 • 12 weeks
|
0.00%
0/228 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
6/233 • Number of events 7 • 12 weeks
|
0.00%
0/228 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
5/233 • Number of events 5 • 12 weeks
|
3.1%
7/228 • Number of events 7 • 12 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
2.6%
6/233 • Number of events 6 • 12 weeks
|
2.2%
5/228 • Number of events 7 • 12 weeks
|
|
Reproductive system and breast disorders
Retrograde ejaculation
|
29.2%
68/233 • Number of events 70 • 12 weeks
|
0.88%
2/228 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Sinusitis
|
2.1%
5/233 • Number of events 6 • 12 weeks
|
0.88%
2/228 • Number of events 3 • 12 weeks
|
Additional Information
Gary Hoel, RPh, PhD, Executive Director of Clinical Research
Watson Laboratories, Inc.
Phone: 801-588-6641
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60