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

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ClinicalTrials.gov Identifier: NCT00599664
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : April 30, 2010
Sponsor:
Information provided by:
Omeros Corporation

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

Condition or disease Intervention/treatment Phase
Urinary Calculi Urinary Stones Urinary Tract Stones Drug: OMS201 Drug: Vehicle Phase 1

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  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2007
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: 1
Drug
Drug: OMS201
OMS201 irrigation solution during surgery

Placebo Comparator: 2
Vehicle
Drug: Vehicle
Vehicle irrigation solution during surgery




Primary Outcome Measures :
  1. Pharmacokinetic [ Time Frame: Day of Surgery ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Day 7 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Scott Houston Omeros Corporation

Responsible Party: Gregory Demopulos, MD, CMO, CEO, Omeros Corporation
ClinicalTrials.gov Identifier: NCT00599664     History of Changes
Other Study ID Numbers: C07-001
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010

Keywords provided by Omeros Corporation:
Urinary Calculi
Urinary Stones
Urinary Tract Stones
Calculi

Additional relevant MeSH terms:
Calculi
Urinary Calculi
Urolithiasis
Pathological Conditions, Anatomical
Urologic Diseases