Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones

Completed · Phase 1/Phase 2

Conditions studied: Urinary Calculi, Urinary Stones, Urinary Tract Stones, Renal Calculi, Kidney Stones

In brief

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.

Key facts

Study ID

NCT00857090

Run by

Omeros Corporation

People needed

18

Starts

2009-03-01

Expected to finish

2010-12-01

Last updated by the study team

2012-10-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California Irvine Medical Center — Orange, California, United States
• Urology Center of Colorado — Denver, Colorado, United States
• Urology Associates — Nasville, Tennessee, United States
• Urology San Antonio Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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