Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857090
• Other study ID #: C08-001
• 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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Renal Calculi
• Urinary Calculi
• Urinary Stones
• Urinary Tract Stones

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