Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Conditions
Keywords
prostatitis, chronic pelvic pain
Brief summary
The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.
Detailed description
A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Interventions
Sponsors
Watson Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male, at least 18 years of age * Has a total NIH-CPSI total score of 15 * Has a NIH-CPSI pain score of 8 * Has had pain in the pelvic region for at least 3 months prior to screening
Exclusion criteria
* Has previously participated in a Watson study with silodosin * Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition * Has experience ≥2 urinary tract infections within the previous 12 months * Has any medical condition that in the opinion of the investigator precludes safe participation in the study * Has any medical condition that could confound the efficacy evaluation * Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study * Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation * Has participated in a study involving the administration of an investigational agent within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Silodosin 4 mg Silodosin 4 mg daily | 52 |
| Silodosin 8 mg Silodosin 8 mg daily | 45 |
| Placebo 1 placebo capsule daily | 54 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 6 | 3 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 3 | 5 |
| Overall Study | Protocol Violation | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 2 |
Baseline characteristics
| Characteristic | Silodosin 8 mg | Placebo | Silodosin 4 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 8 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 51 Participants | 44 Participants | 136 Participants |
| Age Continuous | 46.7 years STANDARD_DEVIATION 15.57 | 49.0 years STANDARD_DEVIATION 11.62 | 49.2 years STANDARD_DEVIATION 13.34 | 48.4 years STANDARD_DEVIATION 13.43 |
| Region of Enrollment United States | 45 participants | 54 participants | 52 participants | 151 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 45 Participants | 54 Participants | 52 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 52 | 25 / 45 | 12 / 54 |
| serious Total, serious adverse events | 2 / 52 | 0 / 45 | 0 / 54 |
Outcome results
Primary
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
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.
Time frame: 12 weeks
Population: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silodosin 4 mg | 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 |
| Silodosin 4 mg | 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 |
| Silodosin 8 mg | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. | Baseline NIH-CPSI Total Score | 26.8 Units on a 0 to 43 scale | Standard Deviation 5.94 |
| Silodosin 8 mg | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. | Chage from Baseline in NIH-CPSI at Week 12 | -10.2 Units on a 0 to 43 scale | Standard Deviation 8.84 |
| Placebo | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. | Baseline NIH-CPSI Total Score | 27.9 Units on a 0 to 43 scale | Standard Deviation 6.21 |
| Placebo | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. | Chage from Baseline in NIH-CPSI at Week 12 | -8.5 Units on a 0 to 43 scale | Standard Deviation 7.23 |