Abacterial Chronic Prostatitis/Chronic Pelvic Pain SyndromePhase 2NCT00740779

Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

A Phase 2 study testing Silodosin 8 mg and Silodosin 4 mg in people with Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome, run by Watson Pharmaceuticals at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
What is being tested?: Silodosin 8 mg and Silodosin 4 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 153 participants
Where: 22 sitesUnited States
Study dates: Sep 2008to Oct 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Watson Investigational Site
Albuquerque, New Mexico
Watson Investigational Site
Baltimore, Maryland
Watson Investigational Site
Bethany, Oklahoma
Watson Investigational Site
Boston, Massachusetts
Watson Investigational Site
Columbus, Georgia
Watson Investigational Site
Columbus, Ohio
Watson Investigational Site
Denver, Colorado
Watson Investigational Site
Edmond, Oklahoma
Watson Investigational Site
Garden City, New York
Watson Investigational Site
Jeffersonville, Indiana
Watson Investigational Site
Kingston, New York
Watson Investigational Site
Mountlake Terrace, Washington
Watson Investigational Site
New York, New York
Watson Investigational Site
Omaha, Nebraska
Watson Investigational Site
Poughkeepsie, New York
Watson Investigational Site
Roswell, Georgia
Watson Investigational Site
San Diego, California
Watson Investigational Site
Spokane, Washington
Watson Investigational Site
State College, Pennsylvania
Watson Investigational Site
Voorhees Township, New Jersey
Watson Investigational Site
Watertown, Massachusetts
Watson Investigational Site
West Des Moines, Iowa

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Being tested: Silodosin 8 mg, Placebo, Silodosin 4 mg
Keywords: prostatitis, chronic pelvic pain
Medical subject headings: Prostatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Silodosin 8 mgDrug
Also called Rapaflo
Silodosin 8 mg daily
PlaceboDrug
Also called Placebo control.
Placebo
Silodosin 4 mgDrug
Also called Rapaflo
Silodosin 4 mg daily

Study groups in NCT00740779
Study group	Role	What they receive
Silodosin 4 mg	Experimental	4 mg daily Receives: Drug: Silodosin 4 mg
Silodosin 8 mg	Experimental	Silodosin 8 mg daily Receives: Drug: Silodosin 8 mg
Placebo	Placebo comparator	1 placebo capsule daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Oct 2009

First posted25 Aug 2008 (estimated)
Study startSep 2008
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Abacterial Chronic Prostatitis/Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00740779
Sponsor's protocol ID: SI08001
Status last verified: Jan 2012
First submitted: 21 Aug 2008
Last updated: 24 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Nickel JC, O'Leary MP, Lepor H, Caramelli KE, Thomas H, Hill LA, Hoel GE. Silodosin for men with chronic prostatitis/chronic pelvic pain syndrome: results of a phase II multicenter, double-blind, placebo controlled study. J Urol. 2011 Jul;186(1):125-31. doi: 10.1016/j.juro.2011.03.028. Epub 2011 May 14.
PubMed 21571345

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00740779
Acronym / sponsor ID: SI08001
Conditions: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Keywords: prostatitis, chronic pelvic pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Watson PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 25 Aug 2008 (estimated)
Results: Posted 24 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Silodosin 4 mg	Experimental	Drug: Silodosin 4 mg4 mg daily
Silodosin 8 mg	Experimental	Drug: Silodosin 8 mgSilodosin 8 mg daily
Placebo	Placebo comparator	Drug: Placebo1 placebo capsule daily

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Silodosin 8 mgAlso: RapafloSilodosin 8 mg daily	Drug	Silodosin 8 mg
PlaceboAlso: Placebo control.Placebo	Drug	Placebo
Silodosin 4 mgAlso: RapafloSilodosin 4 mg daily	Drug	Silodosin 4 mg

Primary outcome

National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
Time frame: 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.

Results and safety

Results posted to the registry on 24 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silodosin 4 mg	52	43
Silodosin 8 mg	45	31
Placebo	54	41

Primary outcome: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Units on a 0 to 43 scale

Measure	Silodosin 4 mg n = 52	Silodosin 8 mg n = 45	Placebo n = 51
Baseline NIH-CPSI Total Score	26.0 (6.29)	26.8 (5.94)	27.9 (6.21)
Chage from Baseline in NIH-CPSI at Week 12	-12.1 (9.32)	-10.2 (8.84)	-8.5 (7.23)

Population analysed: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).

Adverse events

Time frame: 12 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silodosin 4 mg	2 of 52 (3.8%)	22 of 52 (42.3%)	Not reported
Silodosin 8 mg	0 of 45 (0%)	25 of 45 (55.6%)	Not reported
Placebo	0 of 54 (0%)	12 of 54 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21571345Nickel JC, O'Leary MP, Lepor H, Caramelli KE, Thomas H, Hill LA, Hoel GE. Silodosin for men with chronic prostatitis/chronic pelvic pain syndrome: results of a phase II multicenter, double-blind, placebo controlled study. J Urol. 2011 Jul;186(1):125-31. doi: 10.1016/j.juro.2011.03.028. Epub 2011 May 14.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kim Caramelli, MS study director

Watson Pharmaceuticals

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Silodosin 8 mg and Silodosin 4 mg in people with Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome, run by Watson Pharmaceuticals at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00740779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.