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Completed

NCT Number: NCT01952314

Medical Expulsive Therapy for Ureter Stone Using Naftopidil

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.

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Key information

Conditions

Ureter Stones

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Donguk University Ilsan Hospital, Goyang, Kyunggi, South Korea

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About this study

  • Enrollment
  • patients with ureteral stones of sizes from 3 to 10 mm
  • patients aged more than 18 years
  • Randomization
  • naftopidil 75 mg qd for 14 days or placebo
  • Standard treatment with pain-killers were also applied.(aceclofenac)
  • Follow-up for 28 days
  • We confirm the stone free status by CT or X-ray films at 14th and 28th days.
  • Rates of active treatment will be also evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naftopidil 75mg

Drug

naftopidil 75mg 1T qd hs

Other names: Flivas(TM) in South Korea

Placebo for Naftopidil

Drug

Placebo 1T qd hs

standard treatment

Drug

Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand

Other names: Pain control

Primary outcomes

  1. 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 outcomes

  1. Stone-free rate at 28th day of study

    Time frame: 28th day

  2. Duration to stone passage within 28days of study

    Time frame: for 28 days

  3. amount of analgesics used for 28 days of study

    Time frame: for 28 days

  4. Rate of active treatment

    Time frame: for 28 days

    Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dong-A ST Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 27, 2013
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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