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

This study has been completed.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd. Identifier:
First received: February 21, 2012
Last updated: October 29, 2013
Last verified: October 2013
The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.

Condition Intervention Phase
Urinary Calculus Drug: silodosin Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi

Resource links provided by NLM:

Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Spontaneous stone passage rate [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Time to spontaneous stone passage [ Time Frame: 4 weeks ]
  • Analgesic use [ Time Frame: 4 weeks ]
  • Pain severity [ Time Frame: 4 weeks ]

Estimated Enrollment: 300
Arms Assigned Interventions
Experimental: silodosin, arm 1 Drug: silodosin
Experimental: silodosin, arm 2 Drug: silodosin
Placebo Comparator: placebo Drug: placebo


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01539265

Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Study Director: Tatsuro Takei Clinical Development Department, Kissei pharmaceutical Co., Ltd.
  More Information

Responsible Party: Kissei Pharmaceutical Co., Ltd. Identifier: NCT01539265     History of Changes
Other Study ID Numbers: KMD3201
Study First Received: February 21, 2012
Last Updated: October 29, 2013

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
urinary calculus
ureteral stones
medical expulsive therapy

Additional relevant MeSH terms:
Urinary Calculi
Pathological Conditions, Anatomical
Urologic Diseases
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on September 20, 2017