Kidney CalculiPhase 4NCT02011737
Naftopidil 75mg for Improving Clearance of Urinary Stones
A Phase 4 study testing naftopidil 75mg in people with Kidney Calculi and Ureter Calculi, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Kidney Calculi, Ureter Calculi
- What is being tested?
- naftopidil 75mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Apr 2015
- Phase
- Phase 4
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Radio-opaque (identifiable in KUB) ureter or kidney calculi
- size criteria is from 5mm to 15mm
Who cannot join
- Symptomatic acute urinary tract infection during the run-in period
- severe hydronephrosis
- 2 or more urinary stones
- Radiolucent (non-visible in KUB) stone
- recent intervention for the urinary stone within 6 month
- Patients who have ureteral stent
Show all 13Show fewer
- over 2.0 mg/dl of serum creatinine level
- severe hepatic dysfunction
- orthostatic hypotension
- current usage of alpha-adrenergic blocker or calcium channel blocker
- Pregnant or nursing women
- Age under 15 year
- severe or uncontrolled medical conditions
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul
Deok Hyun Han, M.D., +82-10-9933-5125, deokhyun.han@gmail.com
Deok Hyun Han, M.D.
About this study
Official title: The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study
The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones.
Read the detailed description
Prospective, Single-center, Double blind, Randomized controlled trial
Treatment
- Oral Naftopidil 75 mg once daily are given to the patients who are scheduled for shockwave lithotripsy (ESWL) because of ureteral or renal stones.
Follow up Assessments including X-ray(KUB), visual analogue pain scale, are done 2, 4, and 6 weeks after the ESWL.
- Conditions
- Kidney Calculi, Ureter Calculi
- Being tested
- naftopidil 75mg
- Keywords
- Medical Expulsive therapy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naftopidil 75mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Naftopidil | Active comparator | Naftopidil 75mg once daily Receives: Drug: naftopidil 75mg |
| Placebo | Placebo comparator | Placebo once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group
Treatment success is defined as no or less than 3 mm size remnant stone
Measured: 2 weeks after ESWL
Secondary outcomes (4)
Difference of the treatment success rate after ESWL between treatment group and placebo group
Treatment success is defined as no or less than 3 mm size remnant stone
Measured: 4, 6 weeks after ESWL
Adverse Event
Rate of total Adverse Events and Adverse Events relevant to Investigational drug
Measured: 2,4,6weeks
pain scale
visual analogue pain scale due to urinary stone
Measured: baseline, 2, 4, 6 weeks
rate of additional intervention
incidence of additional intervention for the urinary stone ex> ureteral stent insertion, percutaneous nephrostomy, ureteroscopic ureterolithotomy, percutaneous nephrolithotomy, laparoscopic stone removal and so on
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Principal investigator, HAN, DEOK HYUN, Samsung Medical Center
- Investigators
- Deok Hyun Han, M.D., Principal investigator, Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011737
- Sponsor's protocol ID
- SMC2013-08-066
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02011737
- Acronym / sponsor ID
- SMC2013-08-066
- Conditions
- Kidney Calculi, Ureter Calculi
- Keywords
- Medical Expulsive therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 13 Dec 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.
The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones.
Detailed description
Prospective, Single-center, Double blind, Randomized controlled trial
Treatment
- Oral Naftopidil 75 mg once daily are given to the patients who are scheduled for shockwave lithotripsy (ESWL) because of ureteral or renal stones.
Follow up Assessments including X-ray(KUB), visual analogue pain scale, are done 2, 4, and 6 weeks after the ESWL.
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 75mgNaftopidil 75mg once daily |
| Placebo | Placebo comparator | –Placebo once daily |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Radio-opaque (identifiable in KUB) ureter or kidney calculi
- size criteria is from 5mm to 15mm
Key exclusion criteria (13 listed)
- Symptomatic acute urinary tract infection during the run-in period
- severe hydronephrosis
- 2 or more urinary stones
- Radiolucent (non-visible in KUB) stone
- recent intervention for the urinary stone within 6 month
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 |
|---|---|---|
| naftopidil 75mg | Drug | Naftopidil |
Primary outcome
Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group
Time frame: 2 weeks after ESWL
Treatment success is defined as no or less than 3 mm size remnant stone
4 secondary outcomes
Difference of the treatment success rate after ESWL between treatment group and placebo group
Time frame: 4, 6 weeks after ESWL
Adverse Event
Time frame: 2,4,6weeks
pain scale
Time frame: baseline, 2, 4, 6 weeks
rate of additional intervention
Time frame: 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
Related trials for Kidney Calculi
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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.
Deok Hyun Han, M.D. principal investigator
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing naftopidil 75mg in people with Kidney Calculi and Ureter Calculi, run by Samsung Medical Center at 1 site 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deok Hyun Han, MD (82-2-3410-6431, deokhyun.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group (time frame: 2 weeks after ESWL). 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 13 Dec 2013.