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Trial record 20 of 24 for:    "Ureterolithiasis" | "Adrenergic Antagonists"

Study of Silodosin to Facilitate Passage of Urinary Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01144949
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Ureteral Calculi
Kidney Stones
Urolithiasis
Interventions Drug: silodosin
Drug: placebo
Enrollment 239
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Silodsosin Placebo
Hide Arm/Group Description silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Period Title: Overall Study
Started 119 120
Completed 108 106
Not Completed 11 14
Arm/Group Title Silodsosin Placebo Total
Hide Arm/Group Description silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks placebo: one placebo capsule orally, once daily, with food for up to 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 119 120 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 120 participants 239 participants
47.4  (12.5) 46.7  (15.2) 47.0  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 239 participants
Female
47
  39.5%
36
  30.0%
83
  34.7%
Male
72
  60.5%
84
  70.0%
156
  65.3%
1.Primary Outcome
Title Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
Hide Description

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.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Silodsosin Placebo
Hide Arm/Group Description:
silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Overall Number of Participants Analyzed 52 59
Measure Type: Number
Unit of Measure: participants
36 27
2.Primary Outcome
Title Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Silodsosin Placebo
Hide Arm/Group Description:
silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Overall Number of Participants Analyzed 115 117
Measure Type: Number
Unit of Measure: participants
60 52
3.Secondary Outcome
Title Time to Spontaneous Stone Passage (Distal Stones)
Hide Description Time to stone passage for distally-located stones is assessed by entries in subject diaries.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Silodsosin Placebo
Hide Arm/Group Description:
silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Overall Number of Participants Analyzed 52 59
Mean (Standard Error)
Unit of Measure: days
19.6  (1.61) 22.0  (1.47)
4.Secondary Outcome
Title Outpatient Narcotic Analgesic Use for Pain Relief
Hide Description Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Silodsosin Placebo
Hide Arm/Group Description:
silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Overall Number of Participants Analyzed 95 104
Mean (Standard Deviation)
Unit of Measure: Days
5.8  (8.0) 5.5  (6.8)
5.Secondary Outcome
Title Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Silodsosin Placebo
Hide Arm/Group Description:
silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Overall Number of Participants Analyzed 52 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.6  (2.5) -1.9  (3.1)
6.Secondary Outcome
Title Time to Spontaneous Stone Passage (All Stones)
Hide Description Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Silodsosin Placebo
Hide Arm/Group Description:
silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
Overall Number of Participants Analyzed 115 117
Mean (Standard Error)
Unit of Measure: days
22.3  (1.02) 22.9  (1.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Silodsosin Placebo
Hide Arm/Group Description silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
All-Cause Mortality
Silodsosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Silodsosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/119 (1.68%)      2/120 (1.67%)    
Renal and urinary disorders     
Renal colic  2/119 (1.68%)  2 2/120 (1.67%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Silodsosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/119 (22.69%)      8/120 (6.67%)    
Gastrointestinal disorders     
Nausea  9/119 (7.56%)  2/120 (1.67%) 
Vomiting  4/119 (3.36%)  4/120 (3.33%) 
Nervous system disorders     
Dizziness  8/119 (6.72%)  2/120 (1.67%) 
Headache  4/119 (3.36%)  0/120 (0.00%) 
Reproductive system and breast disorders     
Retrograde ejaculation  11/119 (9.24%)  1/120 (0.83%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gary Hoel, RPh PhD, VP Global Brands Clinical Research
Organization: Watson Laboratories, Inc.
Phone: 801 588-6641
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01144949     History of Changes
Other Study ID Numbers: SIL1001
First Submitted: June 14, 2010
First Posted: June 16, 2010
Results First Submitted: February 7, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014