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

Sponsored by:	Omeros Corporation
Information provided by:	Omeros Corporation
ClinicalTrials.gov Identifier:	NCT00599664

Purpose

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

Condition	Intervention	Phase
Urinary Calculi Urinary Stones Urinary Tract Stones	Drug: OMS201 Drug: Vehicle	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:

Pharmacokinetic [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]

Enrollment:	11
Study Start Date:	December 2007
Study Completion Date:	September 2008

Arms	Assigned Interventions
1: Experimental Drug	Drug: OMS201 OMS201 irrigation solution during surgery
2: Placebo Comparator Vehicle	Drug: Vehicle Vehicle irrigation solution during surgery

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599664

Locations

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

Sponsors and Collaborators

Omeros Corporation

Investigators

Study Director:	Paul Strauss, MD	Omeros Corporation
Principal Investigator:	Ralph V Clayman, MD	UC Irvine Medical Center
Principal Investigator:	Margaret S Pearle, MD	University of Texas Southwestern

More Information

Responsible Party:	Omeros Corporation ( Gregory Demopulos, MD, CMO, CEO )
Study ID Numbers:	C07-001
Study First Received:	December 26, 2007
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00599664
Health Authority:	United States: Food and Drug Administration

Keywords provided by Omeros Corporation:

Urinary Calculi
Urinary Stones
Urinary Tract Stones
Calculi

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Calculi

ClinicalTrials.gov processed this record on January 14, 2009