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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00857090
Other study ID # C08-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 4, 2009
Last updated October 10, 2012
Start date March 2009
Est. completion date December 2010

Study information

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

Clinical Trial Summary

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.


Description:

The main objective is to estimate the systemic exposure of OMS201 in retrograde ureteroscopic treatment of upper urinary tract stones. Safety will be assessed by vital signs, laboratory values and adverse events. Exploratory efficacy measures will assess the effect of OMS201 on postoperative pain, duration of surgery and ease of placement of a ureteral access sheath.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
OMS201
Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery
Vehicle
Stages 1-2: Vehicle irrigation solution during surgery

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Omeros Corporation

Country where clinical trial is conducted

United States, 

Outcome

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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