Medical Expulsive Therapy for Ureter Stone Using Naftopidil

NCT01952314 | Completed Phase 3

• 2 other identifiers: SNUBH-URO-2012-03SNUBH-URO-2012-03-MET
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Ureter Stones

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  for 28 days

Study Arms (2)

Control groups with only analgesics

PLACEBO COMPARATOR

Control groups will receive only analgesics.

Drug: Placebo for Naftopidil; Drug: Standard treatment

Naftopidil

ACTIVE COMPARATOR

This interventional group will receive analgesics and naftopidil 75mg po qd.

Drug: Naftopidil 75mg; Drug: Standard treatment

Interventions

Naftopidil 75mg DRUG

naftopidil 75mg 1T qd hs

Also known as: Flivas(TM) in South Korea

Naftopidil

Placebo for Naftopidil DRUG

Placebo 1T qd hs

Control groups with only analgesics

Standard treatment DRUG

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

Also known as: Pain control

Control groups with only analgesics; Naftopidil

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 20 years
• single 3 to 10 mm ureter stone (longest diameter)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Dong-A ST Co., Ltd.: collaborator

Study Sites (6)

Donguk University Ilsan Hospital

Goyang, Kyunggi, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Kyunggi, 463-712, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

National Medical Center

Seoul, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

naftopidil; Analgesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Chang Wook Jeong, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D.

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 27, 2013
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

KR (6)