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

Sponsor

Omeros Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00857090

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

4.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Calculi Urinary Stones Urinary Tract Stones Renal Calculi Kidney Stones	Drug: OMS201 Drug: Vehicle	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Drug	Drug: OMS201 Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery
Placebo Comparator: 2 Vehicle	Drug: Vehicle Stages 1-2: Vehicle irrigation solution during surgery

Arm

Intervention/Treatment

Experimental: 1

Drug

Drug: OMS201

Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery

Placebo Comparator: 2

Vehicle

Drug: Vehicle

Stages 1-2: Vehicle irrigation solution during surgery

Outcome Measures

Primary Outcome Measures

Peak systemic exposure. [Day of surgery]

Secondary Outcome Measures

Safety [Day 7]
Degree of pain [7 days]
Duration of the operation [Day of surgery]
Ease of placement of the ureteral access sheath [Day of surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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