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

This study has been completed.
Sponsor:
Information provided by:
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT00599664
First received: December 26, 2007
Last updated: April 28, 2010
Last verified: April 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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
Experimental: 1
Drug
Drug: OMS201
OMS201 irrigation solution during surgery
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Scott Houston Omeros Corporation
  More Information

No publications provided

Responsible Party: Gregory Demopulos, MD, CMO, CEO, Omeros Corporation
ClinicalTrials.gov Identifier: NCT00599664     History of Changes
Other Study ID Numbers: C07-001
Study First Received: December 26, 2007
Last Updated: April 28, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014