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OpenTrials
Completed

NCT Number: NCT01539265

A Dose-finding Study of Silodosin in Patients With Urinary Calculi

The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at Week 0.
  • Patients who are able to visit the site continually as out-patient during the study

Exclusion criteria

  • Patients who have multiple urethral stones.
  • Patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side.
  • Patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome.
  • Patients who have a clinically significant hepatic or renal disorder.
  • Patients with postural hypotension or with a history of postural hypotension.
  • Patients with a history of sever drug allergy, or patients with a history of hypersensitivity to silodosin.
  • Patients who are pregnant, nursing, or desire pregnancy during the study period, or patients who cannot strictly comply with a physician's contraception directions.

Treatment and study plan

Silodosin

Drug

Placebo

Drug

Primary outcomes

  1. Spontaneous stone passage rate

    Time frame: 4 weeks

Secondary outcomes

  1. Time to spontaneous stone passage

    Time frame: 4 weeks

  2. Analgesic use

    Time frame: 4 weeks

  3. Pain severity

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi

Important dates

First posted
Feb 27, 2012
Registry last updated
Oct 30, 2013

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.

Published trials that share one or more normalized conditions with this study.