Ureter StonesPhase 3NCT01952314
Medical Expulsive Therapy for Ureter Stone Using Naftopidil
A Phase 3 study testing Naftopidil 75mg and Standard treatment in people with Ureter Stones, run by Seoul National University Hospital at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ureter Stones
- What is being tested?
- Naftopidil 75mg and Standard treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 6 sitesSouth Korea
- Study dates
- May 2014to Aug 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
- >= 20 years
- single 3 to 10 mm ureter stone (longest diameter)
Who cannot join
- 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
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- 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
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, Kyunggi
Seoul National University Bundang Hospital
Seongnam, Kyunggi, 463-712
Seoul National University Hospital
Seoul, 110-744
National Medical Center
Seoul
Seoul National University Boramae Medical Center
Seoul
About this study
Official title: Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study
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.
Read the detailed description
- Enrollment
- patients with ureteral stones of sizes from 3 to 10 mm
- patients aged more than 18 years
- Randomization
- naftopidil 75 mg qd for 14 days or placebo
- Standard treatment with pain-killers were also applied.(aceclofenac)
- Follow-up for 28 days
- We confirm the stone free status by CT or X-ray films at 14th and 28th days.
- Rates of active treatment will be also evaluated.
- Conditions
- Ureter Stones
- Being tested
- Naftopidil 75mg, Placebo for Naftopidil, Standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naftopidil 75mgDrug
Also called Flivas(TM) in South Korea
naftopidil 75mg 1T qd hs
Placebo for NaftopidilDrug
Placebo 1T qd hs
Also called Pain control
Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand
| Study group | Role | What they receive |
|---|---|---|
| Control groups with only analgesics | Placebo comparator | Control groups will receive only analgesics. Receives: Drug: Placebo for Naftopidil; Drug: Standard treatment |
| Naftopidil | Active comparator | This interventional group will receive analgesics and naftopidil 75mg po qd. Receives: Drug: Naftopidil 75mg; Drug: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14th day
Secondary outcomes (4)
Stone-free rate at 28th day of study
Measured: 28th day
Duration to stone passage within 28days of study
Measured: for 28 days
amount of analgesics used for 28 days of study
Measured: for 28 days
Rate of active treatment
Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment
Measured: for 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter StonesStudies 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
- 150 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
- NCT01952314
- Sponsor's protocol ID
- SNUBH-URO-2012-03
- Other IDs
- SNUBH-URO-2012-03-MET
- 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
- Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01952314
- Acronym / sponsor ID
- SNUBH-URO-2012-03
- Conditions
- Ureter Stones
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Sep 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 investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.
Detailed description
- Enrollment
- patients with ureteral stones of sizes from 3 to 10 mm
- patients aged more than 18 years
- Randomization
- naftopidil 75 mg qd for 14 days or placebo
- Standard treatment with pain-killers were also applied.(aceclofenac)
- Follow-up for 28 days
- We confirm the stone free status by CT or X-ray films at 14th and 28th days.
- Rates of active treatment will be also evaluated.
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 |
|---|---|---|
| Control groups with only analgesics | Placebo comparator | Drug: Placebo for Naftopidil, Drug: Standard treatmentControl groups will receive only analgesics. |
| Naftopidil | Active comparator | Drug: Naftopidil 75mg, Drug: Standard treatmentThis interventional group will receive analgesics and naftopidil 75mg po qd. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >= 20 years
- single 3 to 10 mm ureter stone (longest diameter)
Key exclusion criteria (11 listed)
- 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
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 75mgAlso: 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: Pain controlAceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand | Drug | Control groups with only analgesics, Naftopidil |
Primary outcome
Stone-free rate at 14th day of study
Time frame: 14th day
Rate of stone-free as confirmed by non-contrast CT, intravenous urography or simple x-ray (only for radio-opaque stone)
4 secondary outcomes
Stone-free rate at 28th day of study
Time frame: 28th day
Duration to stone passage within 28days of study
Time frame: for 28 days
amount of analgesics used for 28 days of study
Time frame: for 28 days
Rate of active treatment
Time frame: for 28 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 75mg and Standard treatment in people with Ureter Stones, 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 2 inclusion and 11 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?
Stone-free rate at 14th day of study (time frame: 14th day). 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.