Trial Outcomes & Findings for A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo (NCT NCT00224120)
NCT ID: NCT00224120
Last Updated: 2009-12-15
Results Overview
International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
462 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2009-12-15
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
|
229
|
|
Overall Study
COMPLETED
|
211
|
205
|
|
Overall Study
NOT COMPLETED
|
22
|
24
|
Reasons for withdrawal
| Measure |
Silodosin
Silodosin 8 mg once daily with food
|
Placebo
Matching placebo capsule once daily with food
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
10
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Other
|
4
|
5
|
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=229 Participants
Matching placebo capsule once daily with food
|
Total
n=462 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
|
123 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
110 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Age Continuous
|
64.8 years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 8.23 • n=7 Participants
|
65.1 years
STANDARD_DEVIATION 8.21 • 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
|
233 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
462 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
233 participants
n=5 Participants
|
229 participants
n=7 Participants
|
462 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms
Outcome measures
| Measure |
Silodosin
n=233 Participants
Silodosin 8 mg once daily with food
|
Placebo
n=229 Participants
Matching placebo capsule once daily with food
|
|---|---|---|
|
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
Change from baseline in IPSS at Week 12
|
-6.3 Units on a scale
Standard Deviation 6.54
|
-3.4 Units on a scale
Standard Deviation 5.83
|
|
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
Baseline IPSS
|
21.2 Units on a scale
Standard Deviation 4.88
|
21.2 Units on a scale
Standard Deviation 4.92
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksOutcome measures
| Measure |
Silodosin
n=233 Participants
Silodosin 8 mg once daily with food
|
Placebo
n=229 Participants
Matching placebo capsule once daily with food
|
|---|---|---|
|
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks
Baseline Qmax
|
8.4 mL/min
Standard Deviation 2.48
|
8.7 mL/min
Standard Deviation 2.67
|
|
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks
Change from baseline in Qmax at Week 12
|
2.9 mL/min
Standard Deviation 4.53
|
1.9 mL/min
Standard Deviation 4.82
|
Adverse Events
Silodosin
Serious events: 3 serious events
Other events: 99 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Silodosin
n=233 participants at risk
Silodosin 8 mg once daily with food
|
Placebo
n=229 participants at risk
Matching placebo capsule once daily with food
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block third degree
|
0.43%
1/233 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Carotid artery stenosis
|
0.43%
1/233 • Number of events 1
|
0.00%
0/229
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/233
|
0.44%
1/229 • Number of events 1
|
|
Surgical and medical procedures
Lesion excision
|
0.00%
0/233
|
0.44%
1/229 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/233
|
0.44%
1/229 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/233
|
0.44%
1/229 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/233
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.43%
1/233 • Number of events 1
|
0.00%
0/229
|
Other adverse events
| Measure |
Silodosin
n=233 participants at risk
Silodosin 8 mg once daily with food
|
Placebo
n=229 participants at risk
Matching placebo capsule once daily with food
|
|---|---|---|
|
Reproductive system and breast disorders
Retrograde ejaculation
|
27.0%
63/233 • Number of events 64
|
0.87%
2/229 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
3.9%
9/233 • Number of events 9
|
0.44%
1/229 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
6/233 • Number of events 6
|
1.3%
3/229 • Number of events 3
|
|
Vascular disorders
Orthostatic hypotension
|
2.6%
6/233 • Number of events 6
|
0.87%
2/229 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
5/233 • Number of events 5
|
0.00%
0/229
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
5/233 • Number of events 6
|
2.2%
5/229 • Number of events 5
|
|
Investigations
Prostatic specific antigen increased
|
2.1%
5/233 • Number of events 5
|
0.87%
2/229 • Number of events 2
|
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