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: August 7, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to assess if patients treated with sildosin 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 without need for emergency department visits, hospital admissions, surgical intervention, or other interventional procedures. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to spontaneous stone passage. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Need for outpatient narcotic analgesic use for pain relief. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pain scale ratings. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
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
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
Last Updated: August 7, 2013
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
Ureteral Calculi
Ureterolithiasis
Urinary Calculi
Urolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Ureteral Diseases

ClinicalTrials.gov processed this record on April 15, 2014