Trial Outcomes & Findings for Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome. (NCT NCT00740779)
NCT ID: NCT00740779
Last Updated: 2012-02-24
Results Overview
Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
12 weeks
Results posted on
2012-02-24
Participant Flow
Participant milestones
| Measure |
Silodosin 4 mg
Silodosin 4 mg daily
|
Silodosin 8 mg
Silodosin 8 mg daily
|
Placebo
1 placebo capsule daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
45
|
54
|
|
Overall Study
COMPLETED
|
43
|
31
|
41
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
13
|
Reasons for withdrawal
| Measure |
Silodosin 4 mg
Silodosin 4 mg daily
|
Silodosin 8 mg
Silodosin 8 mg daily
|
Placebo
1 placebo capsule daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
5
|
Baseline Characteristics
Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Baseline characteristics by cohort
| Measure |
Silodosin 4 mg
n=52 Participants
Silodosin 4 mg daily
|
Silodosin 8 mg
n=45 Participants
Silodosin 8 mg daily
|
Placebo
n=54 Participants
1 placebo capsule daily
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
136 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
|
Age Continuous
|
49.2 years
STANDARD_DEVIATION 13.34 • n=39 Participants
|
46.7 years
STANDARD_DEVIATION 15.57 • n=41 Participants
|
49.0 years
STANDARD_DEVIATION 11.62 • n=35 Participants
|
48.4 years
STANDARD_DEVIATION 13.43 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
54 Participants
n=35 Participants
|
151 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=39 Participants
|
45 participants
n=41 Participants
|
54 participants
n=35 Participants
|
151 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.
Outcome measures
| Measure |
Silodosin 4 mg
n=52 Participants
Silodosin 4 mg daily
|
Silodosin 8 mg
n=45 Participants
Silodosin 8 mg daily
|
Placebo
n=51 Participants
1 placebo capsule daily
|
|---|---|---|---|
|
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
Chage from Baseline in NIH-CPSI at Week 12
|
-12.1 Units on a 0 to 43 scale
Standard Deviation 9.32
|
-10.2 Units on a 0 to 43 scale
Standard Deviation 8.84
|
-8.5 Units on a 0 to 43 scale
Standard Deviation 7.23
|
|
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
Baseline NIH-CPSI Total Score
|
26.0 Units on a 0 to 43 scale
Standard Deviation 6.29
|
26.8 Units on a 0 to 43 scale
Standard Deviation 5.94
|
27.9 Units on a 0 to 43 scale
Standard Deviation 6.21
|
Adverse Events
Silodosin 4 mg
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Silodosin 8 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Silodosin 4 mg
n=52 participants at risk
Silodosin 4 mg daily
|
Silodosin 8 mg
n=45 participants at risk
Silodosin 8 mg daily
|
Placebo
n=54 participants at risk
1 placebo capsule daily
|
|---|---|---|---|
|
Infections and infestations
Urosepsis
|
1.9%
1/52 • Number of events 1 • 12 weeks
|
0.00%
0/45 • 12 weeks
|
0.00%
0/54 • 12 weeks
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Number of events 1 • 12 weeks
|
0.00%
0/45 • 12 weeks
|
0.00%
0/54 • 12 weeks
|
Other adverse events
| Measure |
Silodosin 4 mg
n=52 participants at risk
Silodosin 4 mg daily
|
Silodosin 8 mg
n=45 participants at risk
Silodosin 8 mg daily
|
Placebo
n=54 participants at risk
1 placebo capsule daily
|
|---|---|---|---|
|
Reproductive system and breast disorders
Retrograde Ejaculation
|
26.9%
14/52 • Number of events 15 • 12 weeks
|
40.0%
18/45 • Number of events 18 • 12 weeks
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
1.9%
1/52 • Number of events 1 • 12 weeks
|
11.1%
5/45 • Number of events 5 • 12 weeks
|
7.4%
4/54 • Number of events 5 • 12 weeks
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • 12 weeks
|
4.4%
2/45 • Number of events 3 • 12 weeks
|
3.7%
2/54 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.8%
2/52 • Number of events 2 • 12 weeks
|
6.7%
3/45 • Number of events 5 • 12 weeks
|
0.00%
0/54 • 12 weeks
|
|
Infections and infestations
Sinusitis
|
5.8%
3/52 • Number of events 4 • 12 weeks
|
4.4%
2/45 • Number of events 2 • 12 weeks
|
0.00%
0/54 • 12 weeks
|
|
Reproductive system and breast disorders
Libido Decreased
|
1.9%
1/52 • Number of events 1 • 12 weeks
|
4.4%
2/45 • Number of events 2 • 12 weeks
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/52 • Number of events 1 • 12 weeks
|
2.2%
1/45 • Number of events 3 • 12 weeks
|
3.7%
2/54 • Number of events 3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
1/52 • Number of events 1 • 12 weeks
|
0.00%
0/45 • 12 weeks
|
3.7%
2/54 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
2/52 • Number of events 2 • 12 weeks
|
0.00%
0/45 • 12 weeks
|
0.00%
0/54 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/52 • 12 weeks
|
0.00%
0/45 • 12 weeks
|
5.6%
3/54 • Number of events 3 • 12 weeks
|
|
Renal and urinary disorders
Neurogenic Bladder
|
3.8%
2/52 • Number of events 2 • 12 weeks
|
0.00%
0/45 • 12 weeks
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.8%
3/52 • Number of events 3 • 12 weeks
|
0.00%
0/45 • 12 weeks
|
0.00%
0/54 • 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