Medical Expulsive Therapy for Ureter Stone Using Naftopidil

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Seoul National University Hospital
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Chang Wook Jeong, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01952314
First received: September 24, 2013
Last updated: April 26, 2015
Last verified: April 2015
  Purpose

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 po qd
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Duration to stone passage within 28days of study [ Time Frame: for 28 days ] [ Designated as safety issue: No ]
  • amount of analgesics used for 28 days of study [ Time Frame: for 28 days ] [ Designated as safety issue: No ]
  • Rate of active treatment [ Time Frame: for 28 days ] [ Designated as safety issue: No ]
    Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment


Estimated Enrollment: 150
Study Start Date: May 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 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.
Active Comparator: Naftopidil
This interventional group will receive analgesics and naftopidil 75mg po qd.
Drug: Naftopidil 75mg po qd
naftopidil 75mg po qd for 28 days with standard analgesic treatment
Other Name: Flivas(TM) in South Korea

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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952314

Contacts
Contact: Chang Wook Jeong, M.D., Ph.D. 82-10-8933-4353 drboss@korea.com
Contact: Sung Yong Cho, M.D., Ph.D. 82-10-6287-0217 kmoretry@daum.net

Locations
Korea, Republic of
Donguk University Ilsan Hospital Recruiting
Goyang, Kyunggi, Korea, Republic of
Contact: Minchul Cho, M.D., Ph.D.         
Principal Investigator: Minchul Cho, M.D., Ph.D.         
Seoul National University Bundang Hospital Recruiting
Seongnam, Kyunggi, Korea, Republic of, 463-712
Contact: Sangchul Lee, M.D., Ph.D.         
Principal Investigator: Sangchul Lee, M.D., Ph.D.         
Sub-Investigator: Jong Jin Oh, M.D., Ph.D.         
Kangwon National University Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Sang Wook Lee, M.D., Ph.D.         
Principal Investigator: Sang Wook Lee, M.D., Ph.D.         
Sub-Investigator: Hong Zoo Park, M.D., Ph.D.         
National Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Woong Na, M.D., Ph.D.         
Principal Investigator: Woong Na, M.D., Ph.D.         
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sung Yong Cho, M.D., Ph.D.       kmoretry@daum.net   
Principal Investigator: Sung Yong Cho, M.D., Ph.D.         
Sub-Investigator: Seung Bae Lee, M.D., Ph.D.         
Sub-Investigator: Hyun Jeong, M.D., Ph.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Chang Wook Jeong, M.D., Ph.D.    +82-2-2072-3899    drboss@korea.com   
Principal Investigator: Chang Wook Jeong, M.D., Ph.D.         
Sponsors and Collaborators
Seoul National University Hospital
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: Chang Wook Jeong, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Chang Wook Jeong, M.D, Ph.D., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01952314     History of Changes
Other Study ID Numbers: SNUBH-URO-2012-03, SNUBH-URO-2012-03-MET
Study First Received: September 24, 2013
Last Updated: April 26, 2015
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Ureteral Diseases
Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Urologic Diseases
Analgesics
Naftopidil
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Hematologic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015