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| Name | Class |
|---|---|
| Dong-A ST Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftopidil | Active Comparator | Naftopidil 75mg once daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naftopidil 75mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse Event |
| Measure | Description | Time Frame |
|---|---|---|
| time to stone expulsion | the time (days) elapsed from first ESWL to the expulsion of the stone | 2,4,6week |
| Number of ESWL | The number of required ESWL for the stone expulsion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deok Hyun Han, MD | Contact | 82-2-3410-6431 | deokhyun.han@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Deok Hyun Han, M.D. | Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C064357 | naftopidil |
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Rate of total Adverse Events and Adverse Events relevant to Investigational drug
| 2,4,6weeks |
| pain scale | visual analogue pain scale due to urinary stone | baseline, 2, 4, 6 weeks |
| 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 |
| 6week |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |