Ureter Stones
Conditions
Brief summary
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
1. Enrollment 1. patients with ureteral stones of sizes from 3 to 10 mm 2. patients aged more than 18 years 2. Randomization 1. naftopidil 75 mg qd for 14 days or placebo 2. Standard treatment with pain-killers were also applied.(aceclofenac) 3. Follow-up for 28 days 1. We confirm the stone free status by CT or X-ray films at 14th and 28th days. 2. Rates of active treatment will be also evaluated.
Interventions
DRUGNaftopidil 75mg
naftopidil 75mg 1T qd hs
Placebo 1T qd hs
DRUGStandard treatment
Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand
Sponsors
Dong-A ST Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free rate at 14th day of study | 14th day | Rate of stone-free as confirmed by non-contrast CT, intravenous urography or simple x-ray (only for radio-opaque stone) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | for 28 days | Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment |
Countries
South Korea
Outcome results
None listed