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

Phase 1

Completed

• Conditions: Urinary Calculi; Urinary Tract Stones; Urinary Stones; Kidney Stones; Renal Calculi
• Interventions: Drug: Vehicle; Drug: OMS201

• Registration Number: NCT00857090
• Lead Sponsor: Omeros Corporation

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-10
• Disposition First Submitted: 2012-10-10
• Disposition First Submitted QC: 2012-10-10
• Last Update Submitted: 2012-10-10
• Disposition First Posted: 2012-10-12
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Vehicle	Vehicle
1	OMS201	Drug

Primary Outcome Measures

Name	Time	Method
Peak systemic exposure.	Day of surgery

Secondary Outcome Measures

Name	Time	Method
Degree of pain	7 days
Safety	Day 7
Duration of the operation	Day of surgery
Ease of placement of the ureteral access sheath	Day of surgery

Trial Locations

Locations (4)

Urology Associates; 🇺🇸 Nasville, Tennessee, United States

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

Urology Center of Colorado; 🇺🇸 Denver, Colorado, United States

Urology San Antonio Research; 🇺🇸 San Antonio, Texas, United States