Naftopidil 75mg for Improving Clearance of Urinary Stones

Kidney Calculi Clinical Trial

Official title:

The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02011737
• Other study ID #: SMC2013-08-066
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 10, 2013
• Last updated: December 10, 2013
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: Deok Hyun Han, MD
• Phone: 82-2-3410-6431
• Email: deokhyun.han[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug SafetySouth Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones.

Description:

Prospective, Single-center, Double blind, Randomized controlled trial

Treatment

• Oral Naftopidil 75 mg once daily are given to the patients who are scheduled for shockwave lithotripsy (ESWL) because of ureteral or renal stones.

Follow up Assessments including X-ray(KUB), visual analogue pain scale, are done 2, 4, and 6 weeks after the ESWL.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Radio-opaque (identifiable in KUB) ureter or kidney calculi

• size criteria is from 5mm to 15mm

Exclusion Criteria:

• Symptomatic acute urinary tract infection during the run-in period

• severe hydronephrosis

• 2 or more urinary stones

• Radiolucent (non-visible in KUB) stone

• recent intervention for the urinary stone within 6 month

• Patients who have ureteral stent

• over 2.0 mg/dl of serum creatinine level

• severe hepatic dysfunction

• orthostatic hypotension

• current usage of alpha-adrenergic blocker or calcium channel blocker

• Pregnant or nursing women

• Age under 15 year

• severe or uncontrolled medical conditions

Study Design

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Ureter Calculi
• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• naftopidil 75mg

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to stone expulsion	the time (days) elapsed from first ESWL to the expulsion of the stone	2,4,6week	No
Other	Number of ESWL	The number of required ESWL for the stone expulsion	6week	No
Primary	Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group	Treatment success is defined as no or less than 3 mm size remnant stone	2 weeks after ESWL	No
Secondary	Difference of the treatment success rate after ESWL between treatment group and placebo group	Treatment success is defined as no or less than 3 mm size remnant stone	4, 6 weeks after ESWL	No
Secondary	Adverse Event	Rate of total Adverse Events and Adverse Events relevant to Investigational drug	2,4,6weeks	Yes
Secondary	pain scale	visual analogue pain scale due to urinary stone	baseline, 2, 4, 6 weeks	No
Secondary	rate of additional intervention	incidence of additional intervention for the urinary stone ex> ureteral stent insertion, percutaneous nephrostomy, ureteroscopic ureterolithotomy, percutaneous nephrolithotomy, laparoscopic stone removal and so on	6 week	No