Medical Expulsive Therapy for Ureter Stone Using Naftopidil

Ureter Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952314
• Other study ID #: SNUBH-URO-2012-03
• Secondary ID: SNUBH-URO-2012-0
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2013
• Last updated: December 8, 2015
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ureter Stones
• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• Naftopidil 75mg
naftopidil 75mg 1T qd hs
• Placebo for Naftopidil
Placebo 1T qd hs
• Standard treatment
Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand

Locations

Country	Name	City	State
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Donguk University Ilsan Hospital	Goyang	Kyunggi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyunggi
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Stone-free rate at 28th day of study		28th day	No
Secondary	Duration to stone passage within 28days of study		for 28 days	No
Secondary	amount of analgesics used for 28 days of study		for 28 days	No
Secondary	Rate of active treatment	Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment	for 28 days	No