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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Urinary CalculiUrinary StonesUrinary Tract StonesRenal CalculiKidney Stones
Interventions
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

Trial Locations (4)

37209

Urology Associates, Nasville

78229

Urology San Antonio Research, San Antonio

80211

Urology Center of Colorado, Denver

92868

University of California Irvine Medical Center, Orange

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Omeros Corporation

INDUSTRY

NCT00857090 - Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones | Biotech Hunter | Biotech Hunter