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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Calculi; Renal Calculi; Kidney Stones; Urinary Stones; Urinary Tract Stones
• Intervention / Treatment: Drug: OMS201; Drug: Vehicle

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center
  • Colorado
    • Denver, Colorado, United States, 80211
      • Urology Center of Colorado
  • Tennessee
    • Nasville, Tennessee, United States, 37209
      • Urology Associates
  • Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Vehicle	Drug: Vehicle; Stages 1-2: Vehicle irrigation solution during surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak systemic exposure.	Day of surgery

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Omeros Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 4, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): October 12, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Calculi; Ureteroscopy; Kidney Stones; Urinary Calculi; Renal Calculi; Urinary Tract Stones; Urinary Stones; Urolithotomy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Urolithiasis; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: C08-001