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

Phase 4

• Conditions: Ureteral Calculi
• Interventions: Other: Placebo; Drug: Tamsulosin Hydrochloride OCAS 0.4 mg

• Registration Number: NCT01167062
• Lead Sponsor: Chiang Mai University

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

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-21
• Last Update Submitted: 2010-07-21
• Study First Posted: 2010-07-22
• Last Update Posted: 2010-07-22
• Primary Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Tamsulosin Hydrochloride OCAS 0.4 mg	Tamsulosin Hydrochloride OCAS 0.4 mg	-

Primary Outcome Measures

Name	Time	Method
Stone expulsion rate and time.	28 days

Secondary Outcome Measures

Name	Time	Method
Number of diclofenac injection used	28 days
Rate of occurrence of adverse events	28 days

Trial Locations

Locations (1)

Maharat Nakhon Chiangmai Hospital; 🇹🇭 Muang, Chiangmai, Thailand

Maharat Nakhon Chiangmai Hospital

🇹🇭Muang, Chiangmai, Thailand

Bannakij Lojanapiwat, M.D.

Principal Investigator