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Completed

NCT Number: NCT01144949

Study of Silodosin to Facilitate Passage of Urinary Stones

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.

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Key information

Conditions

Ureteral Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stones Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Colic Signs and Symptoms Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Watson Investigational Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silodosin

Drug

one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks

Placebo

Drug

one placebo capsule orally, once daily, with food for up to 4 weeks

Primary outcomes

  1. Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.

    Time frame: 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.

  2. Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.

    Time frame: 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 outcomes

  1. Time to Spontaneous Stone Passage (Distal Stones)

    Time frame: 4 weeks

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

  2. Outpatient Narcotic Analgesic Use for Pain Relief

    Time frame: 4 weeks

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

  3. Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)

    Time frame: 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.

  4. Time to Spontaneous Stone Passage (All Stones)

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 16, 2010
Registry last updated
Aug 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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