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

Study Overview
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: OMS201
* Drug: Vehicle


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug | Drug: OMS201<br>* 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<br>|
| Placebo Comparator: 2<br>Vehicle | Drug: Vehicle<br>* Stages 1-2: Vehicle irrigation solution during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak systemic exposure. |  | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Calculi, Urinary Stones, Urinary Tract Stones, Renal Calculi, Kidney Stones, Calculi, Urolithotomy, Ureteroscopy