Medical Expulsive Therapy for Ureter Stone Using Naftopidil

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

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.

Study Overview

• Status: Completed
• Conditions: Ureter Stones
• Intervention / Treatment: Drug: Placebo for Naftopidil; Drug: Standard treatment; Drug: Naftopidil 75mg

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of
    • Kangwon National University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • National medical center
  • Seoul, Korea, Republic of
    • Seoul National University Boramae Medical Center
  • Kyunggi
    • Goyang, Kyunggi, Korea, Republic of
      • Donguk University Ilsan Hospital
    • Seongnam, Kyunggi, Korea, Republic of, 463-712
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Platelet Aggregation Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Adrenergic alpha-Antagonists; Naftopidil
• Other Study ID Numbers: SNUBH-URO-2012-03; SNUBH-URO-2012-03-MET (Other Identifier: SNU Bundang Hospital IRB)