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

NCT ID: NCT00599664

Last Updated: 2010-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-09-30

Brief Summary

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

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.

Conditions

Urinary Calculi; Urinary Stones; Urinary Tract Stones

Keywords

Urinary Calculi; Urinary Stones; Urinary Tract Stones; Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Drug

Group Type: EXPERIMENTAL

OMS201

Intervention Type: DRUG

OMS201 irrigation solution during surgery

2

Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle irrigation solution during surgery

Interventions

OMS201

OMS201 irrigation solution during surgery

Intervention Type: DRUG

Vehicle

Vehicle irrigation solution during surgery

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omeros Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Omeros Corporation

Principal Investigators

Scott Houston

Role: STUDY_DIRECTOR

Omeros Corporation

Locations

UC Irvine Medical Center

Orange, California, United States

University of Texas Southwestern

Dallas, Texas, United States

Countries

United States

Other Identifiers

C07-001

Identifier Type: -

Identifier Source: org_study_id