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

Ureteral Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01167062
• Other study ID #: TAM040-0109
• Status: Recruiting
• Phase: Phase 4
• First received: July 16, 2010
• Last updated: July 21, 2010
• Start date: June 2010

Study information

• Verified date: June 2010
• Source: ChaingMai University
• Contact: Bannakij Lojanapiwat, M.D.
• Phone: 66-53-945532
• Email: blojanap[@]mail.med.cmu.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ureteral Calculi
• Ureterolithiasis

Intervention

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

Other:
• Placebo
One tablet OD for a maximum of 28 days

Locations

Country	Name	City	State
Thailand	Maharat Nakhon Chiangmai Hospital	Muang	Chiangmai

Sponsors (1)

Lead Sponsor	Collaborator
ChaingMai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone expulsion rate and time.		28 days	No
Secondary	Number of diclofenac injection used		28 days	No
Secondary	Rate of occurrence of adverse events		28 days	Yes