Medical Expulsive Therapy for Ureter Stone Using Naftopidil

Study Overview
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Brief Summary
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This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

Detailed Description
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Enrollment patients with ureteral stones of sizes from 3 to 10 mm patients aged more than 18 years Randomization naftopidil 75 mg qd for 14 days or placebo Standard treatment with pain-killers were also applied.(aceclofenac) Follow-up for 28 days We confirm the stone free status by CT or X-ray films at 14th and 28th days. Rates of active treatment will be also evaluated.

Official Title
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Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study

Conditions
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Ureter Stones

Intervention / Treatment
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* Drug: Naftopidil 75mg
* Drug: Placebo for Naftopidil
* Drug: Standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 20 years single 3 to 10 mm ureter stone (longest diameter) Exclusion Criteria: Presence of multiple ureter stones Renal insufficiency (serum Cr > 1.4 mg/dL) Febrile urinary tract infections(fever > 38°C, evidence of urinary infection) pregnancy or breast feeding solitary kidney hypersensitivity to naftopidil current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks) moderate or severe cardiovascular or cerebrovascular disease hepatic dysfunction (>2 x normal upper limit) significant active medical illness which in the opinion of the investigator would preclude protocol treatment Genetic disorder such as Galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsorption

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control groups with only analgesics<br>Control groups will receive only analgesics. | Drug: Placebo for Naftopidil<br>* Placebo 1T qd hs<br>Drug: Standard treatment<br>* Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand<br>* Other names: Pain control;|
| Active Comparator: Naftopidil<br>This interventional group will receive analgesics and naftopidil 75mg po qd. | Drug: Naftopidil 75mg<br>* naftopidil 75mg 1T qd hs<br>* Other names: Flivas(TM) in South Korea;Drug: Standard treatment<br>* Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand<br>* Other names: Pain control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone-free rate at 14th day of study | Rate of stone-free as confirmed by non-contrast CT, intravenous urography or simple x-ray (only for radio-opaque stone) | 14th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone-free rate at 28th day of study |  | 28th day | 
| Duration to stone passage within 28days of study |  | for 28 days | 
| amount of analgesics used for 28 days of study |  | for 28 days | 
| Rate of active treatment | Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment | for 28 days |