Trial · NCT01144949

Study of Silodosin to Facilitate Passage of Urinary Stones

NCT01144949, Phase 2, Completed, Watson Pharmaceuticals; results first posted 2014-08-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Silodosin to Facilitate Passage of Urinary Stones. Trials, record NCT01144949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01144949

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Trial

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

Title: Study of Silodosin to Facilitate Passage of Urinary Stones
NCT number: NCT01144949
Status: Completed
Phases: Phase 2
Enrollment: 239 participants, actual
Lead sponsor: Watson Pharmaceuticals
Conditions: Ureteral Calculi, Kidney Stones, Urolithiasis
Interventions: silodosin, placebo
First posted: 2010-06-16
Last updated: 2014-08-11
Results first posted: 2014-08-11

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	4 weeks	The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes only those stones located in the distal ureter.
Primary	Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	4 weeks	The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.
Secondary	Time to Spontaneous Stone Passage (Distal Stones)	4 weeks	Time to stone passage for distally-located stones is assessed by entries in subject diaries.
Secondary	Outpatient Narcotic Analgesic Use for Pain Relief	4 weeks	Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.
Secondary	Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)	4 weeks	At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject's daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4.
Secondary	Time to Spontaneous Stone Passage (All Stones)	4 weeks	Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	4 weeks	Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.	participants	NUMBER
SECONDARY	Time to Spontaneous Stone Passage (Distal Stones)	4 weeks	Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.	days	MEAN
SECONDARY	Outpatient Narcotic Analgesic Use for Pain Relief	4 weeks	ITT population	Days	MEAN
SECONDARY	Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)	4 weeks	Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.	units on a scale	MEAN
PRIMARY	Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	4 weeks	This endpoint analyzed all subjects in the ITT population, defined as randomized and received at least one dose of study drug (115 in the 8 mg silodosin arm, 117 in the placebo arm)	participants	NUMBER
SECONDARY	Time to Spontaneous Stone Passage (All Stones)	4 weeks	ITT population	days	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	Silodsosin	36		participants
Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	Placebo	27		participants
Time to Spontaneous Stone Passage (Distal Stones)	Silodsosin	19.6	Standard Error 1.61	days
Time to Spontaneous Stone Passage (Distal Stones)	Placebo	22.0	Standard Error 1.47	days
Outpatient Narcotic Analgesic Use for Pain Relief	Silodsosin	5.8	Standard Deviation 8.0	Days
Outpatient Narcotic Analgesic Use for Pain Relief	Placebo	5.5	Standard Deviation 6.8	Days
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)	Silodsosin	-2.6	Standard Deviation 2.5	units on a scale
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)	Placebo	-1.9	Standard Deviation 3.1	units on a scale
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	Silodsosin	60		participants
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	Placebo	52		participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Silodsosin	119
Overall Study	STARTED	Placebo	120
Overall Study	COMPLETED	Silodsosin	108
Overall Study	COMPLETED	Placebo	106
Overall Study	NOT COMPLETED	Silodsosin	11
Overall Study	NOT COMPLETED	Placebo	14

Source ClinicalTrials.gov

Adverse events12

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
other	Retrograde ejaculation	Reproductive system and breast disorders	Silodsosin	11	119
other	Retrograde ejaculation	Reproductive system and breast disorders	Placebo	1	120
other	Nausea	Gastrointestinal disorders	Silodsosin	9	119
other	Nausea	Gastrointestinal disorders	Placebo	2	120
other	Dizziness	Nervous system disorders	Silodsosin	8	119
other	Dizziness	Nervous system disorders	Placebo	2	120
other	Headache	Nervous system disorders	Silodsosin	4	119
other	Headache	Nervous system disorders	Placebo	0	120
other	Vomiting	Gastrointestinal disorders	Silodsosin	4	119
other	Vomiting	Gastrointestinal disorders	Placebo	4	120

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Silodsosin
Total, all-cause mortality	Placebo
Total, other adverse events	Silodsosin	27	119
Total, other adverse events	Placebo	8	120
Total, serious adverse events	Silodsosin	2	119
Total, serious adverse events	Placebo	2	120

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons3

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

Comparison	Source
Silodsosin vs Placebo: Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	Trial comparisons
Silodsosin vs Placebo: Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	Trial comparisons
Silodsosin vs Placebo: serious adverse events	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.

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GET https://conductscience.org/api/trials/v1/NCT01144949/registered

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