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

NCT ID: NCT00857090

Last Updated: 2012-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Urinary Calculi Urinary Stones Urinary Tract Stones Renal Calculi Kidney Stones

Keywords

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Urinary Calculi Urinary Stones Urinary Tract Stones Renal Calculi Kidney Stones Calculi Urolithotomy Ureteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Drug

Group Type EXPERIMENTAL

OMS201

Intervention Type DRUG

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

2

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Stages 1-2: Vehicle irrigation solution during surgery

Interventions

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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

Intervention Type DRUG

Vehicle

Stages 1-2: Vehicle irrigation solution during surgery

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Omeros Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California Irvine Medical Center

Orange, California, United States

Site Status

Urology Center of Colorado

Denver, Colorado, United States

Site Status

Urology Associates

Nasville, Tennessee, United States

Site Status

Urology San Antonio Research

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C08-001

Identifier Type: -

Identifier Source: org_study_id