Trial Outcomes & Findings for Study of Silodosin to Facilitate Passage of Urinary Stones (NCT NCT01144949)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

239 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Silodsosin silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Overall Study STARTED	119	120
Overall Study COMPLETED	108	106
Overall Study NOT COMPLETED	11	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Silodosin to Facilitate Passage of Urinary Stones

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Silodsosin n=119 Participants silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=120 Participants placebo: one placebo capsule orally, once daily, with food for up to 4 weeks	Total n=239 Participants Total of all reporting groups
Age, Continuous	47.4 years STANDARD_DEVIATION 12.5 • n=5 Participants	46.7 years STANDARD_DEVIATION 15.2 • n=7 Participants	47.0 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	36 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	84 Participants n=7 Participants	156 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Silodsosin n=52 Participants silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=59 Participants placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	36 participants	27 participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Silodsosin n=115 Participants silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=117 Participants placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	60 participants	52 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: 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.

Time to stone passage for distally-located stones is assessed by entries in subject diaries.

Outcome measures

Outcome measures
Measure	Silodsosin n=52 Participants silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=59 Participants placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Time to Spontaneous Stone Passage (Distal Stones)	19.6 days Standard Error 1.61 • Interval 12.0 to 29.0	22.0 days Standard Error 1.47 • Interval 26.0 to

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.

Outcome measures

Outcome measures
Measure	Silodsosin n=95 Participants silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=104 Participants placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Outpatient Narcotic Analgesic Use for Pain Relief	5.8 Days Standard Deviation 8.0	5.5 Days Standard Deviation 6.8

SECONDARY outcome

Timeframe: 4 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Silodsosin n=52 Participants silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=59 Participants placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)	-2.6 units on a scale Standard Deviation 2.5	-1.9 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population

Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.

Outcome measures

Outcome measures
Measure	Silodsosin n=115 Participants silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=117 Participants placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Time to Spontaneous Stone Passage (All Stones)	22.3 days Standard Error 1.02 • Interval 26.0 to 31.0	22.9 days Standard Error 1.00 • Interval 26.0 to

Adverse Events

Silodsosin

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Silodsosin n=119 participants at risk silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=120 participants at risk placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Renal and urinary disorders Renal colic	1.7% 2/119 • Number of events 2	1.7% 2/120 • Number of events 2

Other adverse events

Other adverse events
Measure	Silodsosin n=119 participants at risk silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Placebo n=120 participants at risk placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Reproductive system and breast disorders Retrograde ejaculation	9.2% 11/119	0.83% 1/120
Gastrointestinal disorders Nausea	7.6% 9/119	1.7% 2/120
Nervous system disorders Dizziness	6.7% 8/119	1.7% 2/120
Nervous system disorders Headache	3.4% 4/119	0.00% 0/120
Gastrointestinal disorders Vomiting	3.4% 4/119	3.3% 4/120

Additional Information

Gary Hoel, RPh PhD, VP Global Brands Clinical Research

Watson Laboratories, Inc.

Phone: 801 588-6641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60