Study of Silodosin to Facilitate Passage of Urinary Stones

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01144949
First received: June 14, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.


Condition Intervention Phase
Ureteral Calculi
Kidney Stones
Urolithiasis
Drug: silodosin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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.


  • Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time to Spontaneous Stone Passage (Distal Stones) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Time to stone passage for distally-located stones is assessed by entries in subject diaries.

  • Outpatient Narcotic Analgesic Use for Pain Relief [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.

  • Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 to Spontaneous Stone Passage (All Stones) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.


Enrollment: 239
Study Start Date: June 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: silodsosin Drug: silodosin
one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
Placebo Comparator: placebo Drug: placebo
one placebo capsule orally, once daily, with food for up to 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age or older
  • Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal
  • Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter

Exclusion Criteria:

  • Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis
  • History of previous ureteral surgery or ureteral stricture on affected side
  • History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer
  • Moderate to severe renal impairment or severe liver insufficiency
  • History of significant postural hypotension
  • Is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study
  • History of allergy to alpha-blockers or oxycodone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144949

  Show 27 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Scott Olsen, MPH Watson Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01144949     History of Changes
Other Study ID Numbers: SIL1001
Study First Received: June 14, 2010
Results First Received: February 7, 2014
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
ureteral calculi
renal colic
ureteral stones
kidney stones
medical expulsive therapy

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Urolithiasis
Ureteral Calculi
Ureterolithiasis
Urinary Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Silodosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014