Medical Expulsive Therapy for Ureter Stone Using Naftopidil

Phase 3

Completed

• Conditions: Ureter Stones
• Interventions: Drug: Placebo for Naftopidil; Drug: Naftopidil 75mg; Drug: Standard treatment

• Registration Number: NCT01952314
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Study Start: 2014-05
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• >= 20 years
• single 3 to 10 mm ureter stone (longest diameter)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control groups with only analgesics	Placebo for Naftopidil	Control groups will receive only analgesics.
Naftopidil	Standard treatment	This interventional group will receive analgesics and naftopidil 75mg po qd.
Control groups with only analgesics	Standard treatment	Control groups will receive only analgesics.
Naftopidil	Naftopidil 75mg	This interventional group will receive analgesics and naftopidil 75mg po qd.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Duration to stone passage within 28days of study	for 28 days
Stone-free rate at 28th day of study	28th day
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

Trial Locations

Locations (6)

Donguk University Ilsan Hospital; 🇰🇷 Goyang, Kyunggi, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Kyunggi, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

National Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of