Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones

July 21, 2010 updated by: ChaingMai University

Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study

This is a randomized double blind placebo-controlled study that will assess the efficacy of Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control group.

Study Overview

Status

Unknown

Conditions

Detailed Description

  • patient will be randomized to receive placebo or Tamsulosin OCAS 0.4 mg 1 tablet OD for a maximum of 28 days or until the ureteral stone is passed and sodium diclofenac 50 mg twice a day, for 10 days.
  • All patients will receive 75 mg sodium diclofenac via intramuscular on demand

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

    • Chiangmai
      • Muang, Chiangmai, Thailand, 50200
        • Recruiting
        • Maharat Nakhon Chiangmai Hospital
        • Contact:
        • Principal Investigator:
          • Bannakij Lojanapiwat, M.D.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patient aged => 18 years.
  • Patients who have distal ureteral stones with a size of 4-10 mm
  • Written informed consent has been obtained.

Exclusion Criteria:

  • Patients with history of ureteral surgery
  • Patients with urinary tract infection
  • Patient with diabetes and peptic ulcer
  • Patient with renal dysfunction (elevated of serum creatinine level)
  • Patients with severe hydronephrosis
  • Patients with history of passing stones
  • Pregnancy
  • Patients who desire to withdraw from the study

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
One tablet OD for a maximum of 28 days
Experimental: Tamsulosin Hydrochloride OCAS 0.4 mg
One tablet OD for a maximum of 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stone expulsion rate and time.
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of diclofenac injection used
Time Frame: 28 days
28 days
Rate of occurrence of adverse events
Time Frame: 28 days
28 days

Collaborators and Investigators

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

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 Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Estimate)

July 22, 2010

Last Update Submitted That Met QC Criteria

July 21, 2010

Last Verified

June 1, 2010

More Information

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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