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Medical Expulsive Therapy for Ureter Stone Using Naftopidil

This study has been completed.
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Chang Wook Jeong, Seoul National University Hospital Identifier:
First received: September 24, 2013
Last updated: December 8, 2015
Last verified: December 2015
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.

Condition Intervention Phase
Ureter Stones
Drug: Naftopidil 75mg
Drug: Placebo for Naftopidil
Drug: Standard treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Stone-free rate at 14th day of study [ Time Frame: 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:
  • Stone-free rate at 28th day of study [ Time Frame: 28th day ]
  • Duration to stone passage within 28days of study [ Time Frame: for 28 days ]
  • amount of analgesics used for 28 days of study [ Time Frame: for 28 days ]
  • Rate of active treatment [ Time Frame: for 28 days ]
    Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment

Enrollment: 150
Study Start Date: May 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pain control
Active Comparator: Naftopidil
This interventional group will receive analgesics and naftopidil 75mg po qd.
Drug: Naftopidil 75mg
naftopidil 75mg 1T qd hs
Other Name: Flivas(TM) in South Korea
Drug: Standard treatment
Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand
Other Name: Pain control

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.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01952314

Korea, Republic of
Donguk University Ilsan Hospital
Goyang, Kyunggi, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Kyunggi, Korea, Republic of, 463-712
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
National Medical Center
Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Dong-A ST Co., Ltd.
Principal Investigator: Chang Wook Jeong, M.D., Ph.D. Seoul National University Hospital
  More Information

Responsible Party: Chang Wook Jeong, M.D, Ph.D., Seoul National University Hospital Identifier: NCT01952314     History of Changes
Other Study ID Numbers: SNUBH-URO-2012-03
SNUBH-URO-2012-03-MET ( Other Identifier: SNU Bundang Hospital IRB )
Study First Received: September 24, 2013
Last Updated: December 8, 2015

Additional relevant MeSH terms:
Ureteral Calculi
Ureteral Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Platelet Aggregation Inhibitors processed this record on May 24, 2017