Naftopidil 75mg for Improving Clearance of Urinary Stones

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02011737
• Collaborator: Dong-A ST Co., Ltd. (Industry)
• Enrollment: 130
• Location: 1
• Arms: 2
• Duration (Months): 13.9
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Calculi; Ureter Calculi	Drug: naftopidil 75mg	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study
• Study Start Date: Feb 1, 2014
• Anticipated Primary Completion Date: Feb 1, 2015
• Anticipated Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Naftopidil Naftopidil 75mg once daily	Drug: naftopidil 75mg
Placebo Comparator: Placebo Placebo once daily

Outcome Measures

Primary Outcome Measures

1. Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group [2 weeks after ESWL]

   Treatment success is defined as no or less than 3 mm size remnant stone

Secondary Outcome Measures

1. Difference of the treatment success rate after ESWL between treatment group and placebo group [4, 6 weeks after ESWL]

   Treatment success is defined as no or less than 3 mm size remnant stone

2. Adverse Event [2,4,6weeks]

   Rate of total Adverse Events and Adverse Events relevant to Investigational drug

3. pain scale [baseline, 2, 4, 6 weeks]

   visual analogue pain scale due to urinary stone

4. rate of additional intervention [6 week]

   incidence of additional intervention for the urinary stone ex> ureteral stent insertion, percutaneous nephrostomy, ureteroscopic ureterolithotomy, percutaneous nephrolithotomy, laparoscopic stone removal and so on

Other Outcome Measures

1. time to stone expulsion [2,4,6week]

   the time (days) elapsed from first ESWL to the expulsion of the stone

2. Number of ESWL [6week]

   The number of required ESWL for the stone expulsion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center
• Dong-A ST Co., Ltd.

Investigators

• Principal Investigator: Deok Hyun Han, M.D., Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HAN, DEOK HYUN, Assistant Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02011737
• Other Study ID Numbers: SMC2013-08-066
• First Posted: Dec 13, 2013
• Last Update Posted: Dec 13, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by HAN, DEOK HYUN, Assistant Professor, Samsung Medical Center: Medical Expulsive therapy
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi; Naftopidil

Study Results

No Results Posted as of Dec 13, 2013