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

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ClinicalTrials.gov Identifier: NCT01539265
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Urinary Calculus Drug: silodosin Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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 the National Library of Medicine

Drug Information available for: Silodosin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: silodosin, arm 1 Drug: silodosin
Experimental: silodosin, arm 2 Drug: silodosin
Placebo Comparator: placebo Drug: placebo



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

Secondary Outcome Measures :
  1. Time to spontaneous stone passage [ Time Frame: 4 weeks ]
  2. Analgesic use [ Time Frame: 4 weeks ]
  3. Pain severity [ Time Frame: 4 weeks ]


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539265


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

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01539265     History of Changes
Other Study ID Numbers: KMD3201
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

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

Additional relevant MeSH terms:
Calculi
Urinary Calculi
Pathological Conditions, Anatomical
Urolithiasis
Urologic Diseases
Silodosin
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