Ureteral CalculiPhase 2NCT01144949

Study of Silodosin to Facilitate Passage of Urinary Stones

A Phase 2 study testing silodosin in people with Ureteral Calculi and Kidney Stones, run by Watson Pharmaceuticals at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ureteral Calculi, Kidney Stones, Urolithiasis
What is being tested?: silodosin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 239 participants
Where: 27 sitesUnited States
Study dates: Jun 2010to Jul 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 18 years of age or older
Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal
Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter

Who cannot join

Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis
History of previous ureteral surgery or ureteral stricture on affected side
History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer
Moderate to severe renal impairment or severe liver insufficiency
History of significant postural hypotension
Is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study
History of allergy to alpha-blockers or oxycodone

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Watson Investigational Site
Albany, New York
Watson Investigational Site
Anchorage, Alaska
Watson Investigational Site
Bala-Cynwyd, Pennsylvania
Watson Investigational Site
Birmingham, Alabama
Watson Investigational Site
Cincinnati, Ohio
Watson Investigational Site
Columbus, Ohio
Watson Investigational Site
Dallas, Texas
Watson Investigational Site
Daytona Beach, Florida
Watson Investigational Site
Gainesville, Florida
Watson Investigational Site
Garden City, New York
Watson Investigational Site
Hackensack, New Jersey
Watson Investigational Site
Lancaster, Pennsylvania
Watson Investigative Site
Mission Hills, California
Watson Investigational Site
Mount Laurel, New Jersey
Watson Investigational Site
Murrieta, California
Watson Investigational Site
Myrtle Beach, South Carolina
Watson Investigational Site
New York, New York
Watson Investigative Site
North Kansas City, Missouri
Watson Investigational Site
Orange City, Florida
Watson Investigative Site
Overland Park, Kansas
Watson Investigational Site
Plainview, New York
Watson Investigational Site
San Antonio, Texas
Watson Investigational Site
San Diego, California
Watson Investigational Site
Sewell, New Jersey
Watson Investigational Site
Syracuse, New York
Watson Investigational Site
Virginia Beach, Virginia
Watson Investigational Site
Voorhees Township, New Jersey

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage

The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

Conditions: Ureteral Calculi, Kidney Stones, Urolithiasis
Being tested: silodosin, placebo
Keywords: ureteral calculi, renal colic, ureteral stones, kidney stones, medical expulsive therapy
Medical subject headings: Ureteral Calculi, Kidney Calculi, Urolithiasis, Renal Colic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

silodosinDrug
one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
placeboDrug
one placebo capsule orally, once daily, with food for up to 4 weeks

Study groups in NCT01144949
Study group	Role	What they receive
silodsosin	Active comparator	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 (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography.
For this outcome measure, analysis includes only those stones located in the distal ureter.
Measured: 4 weeks
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.
Measured: 4 weeks

Secondary outcomes (4)

Time to Spontaneous Stone Passage (Distal Stones)
Time to stone passage for distally-located stones is assessed by entries in subject diaries.
Measured: 4 weeks
Outpatient Narcotic Analgesic Use for Pain Relief
Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.
Measured: 4 weeks
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)
At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject's daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4.
Measured: 4 weeks
Time to Spontaneous Stone Passage (All Stones)
Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Jul 2012

First posted16 Jun 2010 (estimated)
Study startJun 2010
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ureteral CalculiStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01144949
Sponsor's protocol ID: SIL1001
Status last verified: Jul 2014
First submitted: 14 Jun 2010
Last updated: 11 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
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RecruitingObservational study
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Ureteral Access Strategies in Retrograde Intrarenal Surgery
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The Effect of Acupuncture on Passing Ureteral Stones
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All Ureteral Calculi trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage
ClinicalTrials.gov ID: NCT01144949
Acronym / sponsor ID: SIL1001
Conditions: Ureteral Calculi, Kidney Stones, Urolithiasis
Keywords: ureteral calculi, renal colic, ureteral stones, kidney stones, medical expulsive therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: Watson PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 16 Jun 2010 (estimated)
Results: Posted 11 Aug 2014

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 assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

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
silodsosin	Active comparator	Drug: silodosin
placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least 18 years of age or older
Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal
Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter

Key exclusion criteria (7 listed)

Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis
History of previous ureteral surgery or ureteral stricture on affected side
History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer
Moderate to severe renal impairment or severe liver insufficiency
History of significant 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
silodosinone silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks	Drug	silodsosin
placeboone placebo capsule orally, once daily, with food for up to 4 weeks	Drug	placebo

Primary outcome

Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
Time frame: 4 weeks
The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes only those stones located in the distal ureter.
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
Time frame: 4 weeks
The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.

4 secondary outcomes

Time to Spontaneous Stone Passage (Distal Stones)
Time frame: 4 weeks
Outpatient Narcotic Analgesic Use for Pain Relief
Time frame: 4 weeks
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)
Time frame: 4 weeks
Time to Spontaneous Stone Passage (All Stones)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 11 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silodsosin	119	108
Placebo	120	106

Primary outcome: Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.

Time frame: 4 weeks. Number. Unit: participants

Measure	Silodsosin n = 52	Placebo n = 59
Value	36	27

Population analysed: Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.

Primary outcome: Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.

Time frame: 4 weeks. Number. Unit: participants

Measure	Silodsosin n = 115	Placebo n = 117
Value	60	52

Population analysed: This endpoint analyzed all subjects in the ITT population, defined as randomized and received at least one dose of study drug (115 in the 8 mg silodosin arm, 117 in the placebo arm)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silodsosin	2 of 119 (1.7%)	27 of 119 (22.7%)	Not reported
Placebo	2 of 120 (1.7%)	8 of 120 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ureteral Calculi

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
RecruitingObservational study
Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
Kidney Calculi, Nephrolithiasis
Not yet recruiting
Ureteral Access Strategies in Retrograde Intrarenal Surgery
Nephrolithiasis, Kidney Calculi
Recruiting
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RecruitingObservational study
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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.

Scott Olsen, MPH study director

Watson Pharmaceuticals, Inc.

27 sites 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 Ureteral Calculi and Kidney Stones, run by Watson Pharmaceuticals at 27 sites in United States.

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 3 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 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. 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?

Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. (time frame: 4 weeks). 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?

On the ClinicalTrials.gov record for NCT01144949.

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 11 Aug 2014.