Disorder of Urinary StentPhase 3NCT01959074
The Effect of Naftopidil for the Double-J Stent Discomfort
A Phase 3 study testing Naftopidil and Standard treatment in people with Disorder of Urinary Stent, run by Seoul National University Hospital at 6 sites in South Korea.
Trial summary
This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Disorder of Urinary Stent
- What is being tested?
- Naftopidil and Standard treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesSouth Korea
- Study dates
- May 2014to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Kangwon National University Hospital
Chuncheon
Donguk University Ilsan Hospital
Goyang
Seoul National University Bundang Hospital
Seongnam, Kyunggi, 463-712
Seoul National University Hospital
Seoul, 110-744
National Medical Center
Seoul
Seoul National University Boramae Hospital
Seoul
About this study
Official title: 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.
Read the detailed description
- Enrollment
- patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days
- patients aged more than 20 years
- Randomization
- naftopidil 75 mg qd or placebo until Double-J stent removal
- Standard treatment with pain-killers on demand were also applied.(aceclofenac)
- Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)
- Conditions
- Disorder of Urinary Stent
- Being tested
- Naftopidil, Placebo for Naftopidil, Standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaftopidilDrug
Also called Flivas(TM) in South Korea
Naftopidil 75mg 1T qd hs
Placebo for NaftopidilDrug
Placebo 1T qd hs
Also called Aceclofenac
aceclofenac 100mg on demand
| Study group | Role | What they receive |
|---|---|---|
| Naftopidil | Active comparator | This interventional group will receive analgesics and naftopidil 75mg po qd. Receives: Drug: Naftopidil; Drug: Standard treatment |
| Control groups with only analgesics | Placebo comparator | Control groups will receive only analgesics Receives: Drug: Placebo for Naftopidil; Drug: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score
DJ stent removal should be done between study day 5 and 15.
Measured: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
USSQ body pain score
Measured: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
Secondary outcomes (5)
USSQ general health score
Measured: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
USSQ work performance score
Measured: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
USSQ sexual matters score
Measured: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
International Prostate Symptom Score(IPSS), QoL score
Measured: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
Total analgesics use
Measured: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Urinary StentStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Principal investigator, Chang Wook Jeong, Seoul National University Hospital
- Investigators
- Chang Wook Jeong, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959074
- Sponsor's protocol ID
- SNUH-URO-2012-04
- Other IDs
- SNUH-URO-2012-04-DJ
- Status last verified
- Dec 2015
- First submitted
- 24 Sep 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Naftopidil for the Double-J Stent Discomfort: Multicenter, Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01959074
- Acronym / sponsor ID
- SNUH-URO-2012-04
- Conditions
- Disorder of Urinary Stent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery.
Detailed description
- Enrollment
- patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days
- patients aged more than 20 years
- Randomization
- naftopidil 75 mg qd or placebo until Double-J stent removal
- Standard treatment with pain-killers on demand were also applied.(aceclofenac)
- Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naftopidil | Active comparator | Drug: Naftopidil, Drug: Standard treatmentThis interventional group will receive analgesics and naftopidil 75mg po qd. |
| Control groups with only analgesics | Placebo comparator | Drug: Placebo for Naftopidil, Drug: Standard treatmentControl groups will receive only analgesics |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaftopidilAlso: Flivas(TM) in South KoreaNaftopidil 75mg 1T qd hs | Drug | Naftopidil |
| Placebo for NaftopidilPlacebo 1T qd hs | Drug | Control groups with only analgesics |
| Standard treatmentAlso: Aceclofenacaceclofenac 100mg on demand | Drug | Control groups with only analgesics, Naftopidil |
Primary outcome
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.
USSQ body pain score
Time frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
5 secondary outcomes
USSQ general health score
Time frame: 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)
USSQ sexual matters score
Time frame: 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)
Total analgesics use
Time frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Wook Jeong, M.D., Ph.D. principal investigator
Seoul National University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naftopidil and Standard treatment in people with Disorder of Urinary Stent, run by Seoul National University Hospital at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.