The Effect of Naftopidil for the Double-J Stent Discomfort

December 8, 2015 updated by: Chang Wook Jeong, Seoul National University Hospital

The Effect of Naftopidil for the Double-J Stent Discomfort: Multicenter, Randomized, Double-blind, Placebo Controlled Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Enrollment

    1. patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days
    2. patients aged more than 20 years

  2. Randomization

    1. naftopidil 75 mg qd or placebo until Double-J stent removal
    2. Standard treatment with pain-killers on demand were also applied.(aceclofenac)
  3. Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chuncheon, Korea, Republic of
        • Kangwon National University Hospital
      • Goyang, Korea, Republic of
        • Donguk University Ilsan Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • National Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University Boramae Hospital
    • Kyunggi
      • Seongnam, Kyunggi, Korea, Republic of, 463-712
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:Patients to be undergone double-J stent indwelling

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Naftopidil
This interventional group will receive analgesics and naftopidil 75mg po qd.
Drug: Naftopidil
Naftopidil 75mg 1T qd hs
Other Names:
  • Flivas(TM) in South Korea
Drug: Standard treatment
aceclofenac 100mg on demand
Other Names:
  • Aceclofenac
PLACEBO_COMPARATOR: Control groups with only analgesics
Control groups will receive only analgesics
Drug: Standard treatment
aceclofenac 100mg on demand
Other Names:
  • Aceclofenac
Drug: Placebo for Naftopidil
Placebo 1T qd hs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score
Time Frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
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
Time Frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
USSQ general health score
Time Frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
USSQ work performance score
Time Frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
USSQ sexual matters score
Time Frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
International Prostate Symptom Score(IPSS), QoL score
Time Frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
Total analgesics use
Time Frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SNUH-URO-2012-04
  • SNUH-URO-2012-04-DJ (OTHER: SNU Hosptial IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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