Urinary CalculusPhase 2NCT01539265
A Dose-finding Study of Silodosin in Patients With Urinary Calculi
A Phase 2 study testing silodosin in people with Urinary Calculus, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Urinary Calculus
- What is being tested?
- silodosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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
- Patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at Week 0.
- Patients who are able to visit the site continually as out-patient during the study
Who cannot join
- Patients who have multiple urethral stones.
- Patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side.
- Patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome.
- Patients who have a clinically significant hepatic or renal disorder.
- Patients with postural hypotension or with a history of postural hypotension.
- Patients with a history of sever drug allergy, or patients with a history of hypersensitivity to silodosin.
- Patients who are pregnant, nursing, or desire pregnancy during the study period, or patients who cannot strictly comply with a physician's contraception directions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi
The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.
- Conditions
- Urinary Calculus
- Being tested
- silodosin, placebo
- Keywords
- urinary calculus, ureteral stones, medical expulsive therapy
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silodosinDrug
silodosinDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| silodosin, arm 1 | Experimental | Not described Receives: Drug: silodosin |
| silodosin, arm 2 | Experimental | Not described Receives: Drug: silodosin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous stone passage rate
Measured: 4 weeks
Secondary outcomes (3)
Time to spontaneous stone passage
Measured: 4 weeks
Analgesic use
Measured: 4 weeks
Pain severity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculusStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatsuro Takei, Study director, Clinical Development Department, Kissei pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539265
- Sponsor's protocol ID
- KMD3201
- Status last verified
- Oct 2013
- First submitted
- 21 Feb 2012
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi
- ClinicalTrials.gov ID
- NCT01539265
- Acronym / sponsor ID
- KMD3201
- Conditions
- Urinary Calculus
- Keywords
- urinary calculus, ureteral stones, medical expulsive therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 27 Feb 2012 (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 the efficacy and the safety of silodosin in urinary calculi patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| silodosin, arm 1 | Experimental | Drug: silodosin |
| silodosin, arm 2 | Experimental | Drug: silodosin |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at Week 0.
- Patients who are able to visit the site continually as out-patient during the study
Key exclusion criteria (7 listed)
- Patients who have multiple urethral stones.
- Patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side.
- Patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome.
- Patients who have a clinically significant hepatic or renal disorder.
- Patients with postural hypotension or with a history of postural hypotension.
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 |
|---|---|---|
| silodosin | Drug | silodosin, arm 1 |
| silodosin | Drug | silodosin, arm 2 |
| placebo | Drug | placebo |
Primary outcome
Spontaneous stone passage rate
Time frame: 4 weeks
3 secondary outcomes
Time to spontaneous stone passage
Time frame: 4 weeks
Analgesic use
Time frame: 4 weeks
Pain severity
Time frame: 4 weeks
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 30 Oct 2013.
Related trials for Urinary Calculus
Not yet recruitingPhase 4
A Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Stones After Extracorporeal Shock Wave Lithotripsy
Calculus of Upper Urinary Tract
Enrolling by invitationObservational study
Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
Urolithiasis, Intrarenal Pressure
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.
Tatsuro Takei study director
Clinical Development Department, Kissei pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing silodosin in people with Urinary Calculus, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
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 7 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 30 Oct 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Spontaneous stone passage rate (time frame: 4 weeks). 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 30 Oct 2013.