Kidney Stones Clinical Trial
Official title:
Double-Blind, Placebo-Controlled, Concentration-Escalating, Pharmacokinetic Study Evaluating the Systemic Absorption, Safety, and Efficacy of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Ureteral- or Renal Collecting System-Located Stones
Verified date | October 2012 |
Source | Omeros Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 18 - 65 years of age. - Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used. Exclusion Criteria: - No allergies to any of the individual ingredients in OMS201. - Subject taking a prohibited medication. - Pregnant woman, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study. - Subject who has had a renal transplant, has a single kidney, has compromised renal function, or has evidence of papillary necrosis. - Subject who has evidence of a clinically significant urinary tract infection. - Subject who has a prior history of open or laparoscopic urinary tract surgery, or a history of a ureteral stricture. - Subject who has congenital anomalies that would engender an increased procedural safety risk. - Subject with a history of clinically significant chronic or episodic hypotension. - Subject's physical examination is significantly abnormal for purposes of the study as determined by the Investigator. - Subject's screening laboratory evaluations are not within normal limits AND abnormal results are determined by the Investigator to be clinically significant. - Subject is at risk from anesthesia. - Subject is on chronic diuretic use. - Subject has a present condition or history of any clinically significant medical disorder and is determined by the Investigator to be an unsuitable candidate for receipt of an investigational drug. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Urology Center of Colorado | Denver | Colorado |
United States | Urology Associates | Nasville | Tennessee |
United States | University of California Irvine Medical Center | Orange | California |
United States | Urology San Antonio Research | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Omeros Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak systemic exposure. | Day of surgery | No | |
Secondary | Safety | Day 7 | Yes | |
Secondary | Degree of pain | 7 days | No | |
Secondary | Duration of the operation | Day of surgery | No | |
Secondary | Ease of placement of the ureteral access sheath | Day of surgery | No |
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