Clinical trial NCT00857090: Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones
Official title: Double-Blind, Placebo-Controlled, Concentration-Escalating, Pharmacokinetic Study Evaluating the Systemic Absorption, Safety, and Efficacy of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Ureteral- or Renal Collecting System-Located Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Urinary Calculi
Urinary Stones
Urinary Tract Stones
Renal Calculi
Kidney Stones
Keywords: Urinary Calculi
Urinary Stones
Urinary Tract Stones
Renal Calculi
Kidney Stones
Calculi
Urolithotomy
Ureteroscopy
Lead sponsor: Omeros Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.

Detailed description: The main objective is to estimate the systemic exposure of OMS201 in retrograde ureteroscopic treatment of upper urinary tract stones. Safety will be assessed by vital signs, laboratory values and adverse events. Exploratory efficacy measures will assess the effect of OMS201 on postoperative pain, duration of surgery and ease of placement of a ureteral access sheath.

Eligibility criteria: Inclusion Criteria:

* 18 - 65 years of age.
* Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used.

Exclusion Criteria:

* No allergies to any of the individual ingredients in OMS201.
* Subject taking a prohibited medication.
* Pregnant woman, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study.
* Subject who has had a renal transplant, has a single kidney, has compromised renal function, or has evidence of papillary necrosis.
* Subject who has evidence of a clinically significant urinary tract infection.
* Subject who has a prior history of open or laparoscopic urinary tract surgery, or a history of a ureteral stricture.
* Subject who has congenital anomalies that would engender an increased procedural safety risk.
* Subject with a history of clinically significant chronic or episodic hypotension.
* Subject's physical examination is significantly abnormal for purposes of the study as determined by the Investigator.
* Subject's screening laboratory evaluations are not within normal limits AND abnormal results are determined by the Investigator to be clinically significant.
* Subject is at risk from anesthesia.
* Subject is on chronic diuretic use.
* Subject has a present condition or history of any clinically significant medical disorder and is determined by the Investigator to be an unsuitable candidate for receipt of an investigational drug.

Primary outcomes:
measure: Peak systemic exposure.
timeFrame: Day of surgery
Secondary outcomes:
measure: Safety
timeFrame: Day 7
measure: Degree of pain
timeFrame: 7 days
measure: Duration of the operation
timeFrame: Day of surgery
measure: Ease of placement of the ureteral access sheath
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Denver
country: United States
facility: Urology Center of Colorado
state: Colorado
city: Nasville
country: United States
facility: Urology Associates
state: Tennessee
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
Study officials:
References: