Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones

Double-Blind, Placebo-Controlled, Two-Center, Pharmacokinetic Study Evaluating the Systemic Absorption and Safety of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Unilateral Ureteral- or Renal Collecting System-Located Stones

Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.

Study Overview

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

Detailed Description

OMS201 is being developed to facilitate endoscopy of the ureters and to reduce postoperative discomfort, such as pain, frequency, urgency and/or difficult urination following endoscopic surgery to remove a urinary tract stone.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • UC Irvine Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern

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:

• Subject is undergoing unilateral ureteroscopic removal of renal collecting system or ureteral stones located in the ureter with a maximum stone diameter of 12 mm, for which general anesthesia will be used.
• Subject's physical examination is within normal limits or examination is clinically non-significant for purposes of the study as determined by the Investigator, and subject is in good general health.
• Subject's laboratory evaluations are within normal limits or evaluations are clinically non-significant as determined by the Investigator.
• Female subject of childbearing potential who is using an effective method of birth control within at least 14 days prior to surgery and has a negative pregnancy test.
• Subject is at minimal risk from anesthesia and is classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 or PS-2.
• Subject's body mass index is between 19 and 35, inclusive, based on the Body Mass Index Table.

Exclusion Criteria:

• Subject taking a prohibited medication.
• Subject who has had a renal transplant, has a single kidney or has evidence of a compromised renal function as measured by abnormal serum creatinine, as judged by the Investigator, or who has evidence of urinary tract infection, or has prior history of open or laparoscopic surgery, or any history of an ureteral stricture.
• Subject who has congenital anomalies that would engender an increased procedural safety risk such as ureteropelvic junction obstruction resulting in severely dilated renal pelvis, duplicated urinary collecting system, horseshoe kidney or vascular anomalies such as renal arteriovenous fistulas or papillary necrosis.
• Subject has bilateral renal or ureteral stones requiring concurrent ureteroscopic removal.
• Subject with clinically significant hypotension at Screening.
• Subject who has a present condition or history of any clinically significant uncontrolled gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, connective tissue, respiratory or other medical disorder as determined by the Investigator.
• Subject on chronic diuretic use.
• Subject who has taken or used an investigational drug or device within 30 days prior to the day of surgery.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Vehicle	Drug: Vehicle; Vehicle irrigation solution during surgery
Experimental: 1; Drug	Drug: OMS201; OMS201 irrigation solution during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic	Day of Surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety	Day 7

Collaborators and Investigators

• Sponsor: Omeros Corporation
• Investigators: Study Director: Scott Houston, Omeros Corporation

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: January 10, 2008
• First Posted (Estimate): January 24, 2008

Study Record Updates

• Last Update Posted (Estimate): April 30, 2010
• Last Update Submitted That Met QC Criteria: April 28, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Calculi; Urinary Calculi; Urinary Tract Stones; Urinary Stones
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Urolithiasis; Calculi
• Other Study ID Numbers: C07-001