Trial · NCT00224107

A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

NCT00224107, Phase 3, Completed, Watson Pharmaceuticals; results first posted 2009-12-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo. Trials, record NCT00224107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00224107

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
NCT number: NCT00224107
Status: Completed
Phases: Phase 3
Enrollment: 461 participants, actual
Lead sponsor: Watson Pharmaceuticals
Conditions: Benign Prostatic Hyperplasia (BPH)
Interventions: Silodosin, Placebo
First posted: 2005-09-22
Last updated: 2011-07-12
Results first posted: 2009-12-03

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	International Prostate Symptom Score (IPSS)	12 weeks	Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
Secondary	Maximum Urine Flow Rate (Qmax)	12 weeks	Change from baseline in maximum urine flow rate (Qmax)at Week 12

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	International Prostate Symptom Score (IPSS)	12 weeks	The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).	Units on a 0 to 35 scale	MEAN
SECONDARY	Maximum Urine Flow Rate (Qmax)	12 weeks	The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).	mL/sec	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
International Prostate Symptom Score (IPSS)	Silodosin	Baseline IPSS	21.5	Standard Deviation 5.38	Units on a 0 to 35 scale
International Prostate Symptom Score (IPSS)	Placebo	Baseline IPSS	21.4	Standard Deviation 4.91	Units on a 0 to 35 scale
International Prostate Symptom Score (IPSS)	Silodosin	Change from Baseline in IPSS at Week 12	-6.5	Standard Deviation 6.73	Units on a 0 to 35 scale
International Prostate Symptom Score (IPSS)	Placebo	Change from Baseline in IPSS at Week 12	-3.6	Standard Deviation 5.85	Units on a 0 to 35 scale
Maximum Urine Flow Rate (Qmax)	Silodosin	Baseline Qmax	9.0	Standard Deviation 2.60	mL/sec
Maximum Urine Flow Rate (Qmax)	Placebo	Baseline Qmax	9.0	Standard Deviation 2.85	mL/sec
Maximum Urine Flow Rate (Qmax)	Silodosin	Change from Baseline in Qmax at Week 12	2.2	Standard Deviation 4.31	mL/sec
Maximum Urine Flow Rate (Qmax)	Placebo	Change from Baseline in Qmax at Week 12	1.2	Standard Deviation 3.81	mL/sec

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Silodosin	233
Overall Study	STARTED	Placebo	228
Overall Study	COMPLETED	Silodosin	202
Overall Study	COMPLETED	Placebo	214
Overall Study	NOT COMPLETED	Silodosin	31
Overall Study	NOT COMPLETED	Placebo	14

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Silodosin	7	233	8
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	228	1
other	Dizziness	Nervous system disorders	Silodosin	6	233	6
other	Dizziness	Nervous system disorders	Placebo	4	228	4
other	Headache	Nervous system disorders	Silodosin	8	233	8
other	Headache	Nervous system disorders	Placebo	3	228	4
other	Insomnia	Nervous system disorders	Silodosin	5	233	5
other	Insomnia	Nervous system disorders	Placebo	0	228	0
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	Silodosin	6	233	7
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	Placebo	0	228	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Silodosin
Total, all-cause mortality	Placebo
Total, other adverse events	Silodosin	116	233
Total, other adverse events	Placebo	24	228
Total, serious adverse events	Silodosin	3	233
Total, serious adverse events	Placebo	3	228

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19371887	RESULT	PubMed
21135869	DERIVED	PubMed
23234617	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Silodosin vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00224107

GET https://conductscience.org/api/trials/v1/NCT00224107/events?page=2

API reference For AI assistants