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

October 29, 2013 updated by: Kissei Pharmaceutical Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Phase II 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo and Other Japanese City, Japan
        • Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
Experimental: silodosin, arm 1
Drug: silodosin
Experimental: silodosin, arm 2
Drug: silodosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spontaneous stone passage rate
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to spontaneous stone passage
Time Frame: 4 weeks
4 weeks
Analgesic use
Time Frame: 4 weeks
4 weeks
Pain severity
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kissei Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Tatsuro Takei, Clinical Development Department, Kissei Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMD3201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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