NCT00857090

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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
DRUG	Vehicle	Stages 1-2: Vehicle irrigation solution during surgery

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-03-06
• Last updated: 2012-10-12

Locations

4 sites across 1 country: United States