NCT01959074

Brief Summary

This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

September 24, 2013

Last Update Submit

December 8, 2015

Conditions

Disorder of Urinary Stent

Outcome Measures

Primary Outcomes (2)

  • Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score

    DJ stent removal should be done between study day 5 and 15.

    at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  • USSQ body pain score

    at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

Secondary Outcomes (5)

  • USSQ general health score

    at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  • USSQ work performance score

    at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  • USSQ sexual matters score

    at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  • International Prostate Symptom Score(IPSS), QoL score

    at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  • Total analgesics use

    at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

Study Arms (2)

Naftopidil

ACTIVE COMPARATOR

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

Drug: NaftopidilDrug: Standard treatment

Control groups with only analgesics

PLACEBO COMPARATOR

Control groups will receive only analgesics

Drug: Placebo for NaftopidilDrug: Standard treatment

Interventions

NaftopidilDRUG

Naftopidil 75mg 1T qd hs

Also known as: Flivas(TM) in South Korea
Naftopidil
Placebo for NaftopidilDRUG

Placebo 1T qd hs

Control groups with only analgesics
Standard treatmentDRUG

aceclofenac 100mg on demand

Also known as: Aceclofenac
Control groups with only analgesicsNaftopidil

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 20 years
  • undergoing unilateral retrograde double J (DJ) stent placement planned for 5-15 days indwelling

You may not qualify if:

  • after percutaneous nephrolithotomy, open or laparoscopic ureterolithotomy presence of ureteral stone
  • renal insufficiency (serum Cr \> 1.4)
  • febrile urinary tract infection (fever \> 38.0°C, evidence of urinary infection )
  • pregnancy or breast feeding
  • solitary kidney
  • hypersensitivity to Naftopidil
  • current use of any alpha blocker, calcium channel blocker, corticosteroid moderate or sever cardiovascular or cerebrovascular disease
  • hepatic dysfunction
  • prior history of pelvic surgery or irradiation
  • prior history of transurethral resection of bladder tumor or prostate surgery
  • significant active medical illness which in the opinion of the investigator would preclude protocol treatment
  • genetic disorder such ad galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Seoul National University Bundang Hospital

Seongnam, Kyunggi, 463-712, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Donguk University Ilsan Hospital

Goyang, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

National Medical Center

Seoul, South Korea

Location

Seoul National University Boramae Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

naftopidilaceclofenac

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

October 9, 2013

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

KR(6)