Status:
COMPLETED
Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones
Lead Sponsor:
Omeros Corporation
Conditions:
Urinary Calculi
Urinary Stones
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 st...
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 adv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00857090
Start Date
March 1 2009
End Date
December 1 2010
Last Update
October 12 2012
Active Locations (4)
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1
University of California Irvine Medical Center
Orange, California, United States, 92868
2
Urology Center of Colorado
Denver, Colorado, United States, 80211
3
Urology Associates
Nasville, Tennessee, United States, 37209
4
Urology San Antonio Research
San Antonio, Texas, United States, 78229