Phase 2 N=239 Randomized Quadruple-blind Treatment

Study of Silodosin to Facilitate Passage of Urinary Stones

Ureteral Calculi · Kidney Stones · Urolithiasis

Bottom Line

View on ClinicalTrials.gov: NCT01144949 ↗

Enrolled (actual)

239

Serious AEs

1.7%

Results posted

Aug 2014

Primary outcome: Primary: Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. — 36; 27 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: silodosin (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Watson Pharmaceuticals
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	36; 27	—
PRIMARY Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.	60; 52	—
SECONDARY Time to Spontaneous Stone Passage (Distal Stones)	19.6; 22.0	—
SECONDARY Outpatient Narcotic Analgesic Use for Pain Relief	5.8; 5.5	—
SECONDARY Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)	-2.6; -1.9	—
SECONDARY Time to Spontaneous Stone Passage (All Stones)	22.3; 22.9	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01144949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.