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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01539265
First received: February 21, 2012
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to spontaneous stone passage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Analgesic use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pain severity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01539265     History of Changes
Other Study ID Numbers: KMD3201
Study First Received: February 21, 2012
Last Updated: October 29, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on July 23, 2014