NCT01539265

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

First QC Date

February 21, 2012

Last Update Submit

October 29, 2013

Conditions

Urinary Calculus

Keywords

urinary calculusureteral stonesmedical expulsive therapy

Outcome Measures

Primary Outcomes (1)

  • Spontaneous stone passage rate

    4 weeks

Secondary Outcomes (3)

  • Time to spontaneous stone passage

    4 weeks

  • Analgesic use

    4 weeks

  • Pain severity

    4 weeks

Study Arms (3)

silodosin, arm 1

EXPERIMENTAL
Drug: silodosin

silodosin, arm 2

EXPERIMENTAL
Drug: silodosin

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

silodosinDRUG
silodosin, arm 1
placeboDRUG
placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Tokyo and Other Japanese City, Japan

Location

MeSH Terms

Conditions

Urinary Calculi

Interventions

silodosin

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Tatsuro Takei

    Clinical Development Department, Kissei pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

JP(1)