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

Primary Purpose

Ureteral Calculi

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Tamsulosin Hydrochloride OCAS 0.4 mg

Placebo

About this trial

This is an interventional treatment trial for Ureteral Calculi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maharat Nakhon Chiangmai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Tamsulosin Hydrochloride OCAS 0.4 mg

Arm Description

Outcomes

Primary Outcome Measures

Stone expulsion rate and time.

Secondary Outcome Measures

Number of diclofenac injection used

Rate of occurrence of adverse events

Full Information

NCT ID

NCT01167062

First Posted

July 16, 2010

Last Updated

July 21, 2010

Sponsor

ChaingMai University

1. Study Identification

Unique Protocol Identification Number

NCT01167062

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

April 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

ChaingMai University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ureteral Calculi

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Tamsulosin Hydrochloride OCAS 0.4 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Tamsulosin Hydrochloride OCAS 0.4 mg

Intervention Description

One tablet OD for a maximum of 28 days

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

One tablet OD for a maximum of 28 days

Primary Outcome Measure Information:

Title

Stone expulsion rate and time.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Number of diclofenac injection used

Time Frame

28 days

Title

Rate of occurrence of adverse events

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bannakij Lojanapiwat, M.D.

Phone

66-53-945532

blojanap@mail.med.cmu.ac.th

Facility Information:

Facility Name

Maharat Nakhon Chiangmai Hospital

City

Muang

State/Province

Chiangmai

ZIP/Postal Code

50200

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bannakij Lojanapiwat, M.D.

Phone

66-53-945532

blojanap@mail.med.cmu.ac.th

First Name & Middle Initial & Last Name & Degree

Bannakij Lojanapiwat, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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