Clinical Trials Logo

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.


Clinical Trial 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. ;


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


NCT number NCT00857090
Study type Interventional
Source Omeros Corporation
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2009
Completion date December 2010

See also
  Status Clinical Trial Phase
Completed NCT02547805 - Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days Phase 2
Completed NCT02579161 - Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy Phase 3
Completed NCT01187745 - Study to Look for Artifact on Computed Tomography (CT) Representing Kidney Stones N/A
Withdrawn NCT00875823 - International Registry for Primary Hyperoxaluria N/A
Completed NCT05519150 - Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.
Recruiting NCT02522689 - Comparison of Ultra-mini PCNL and Micro PCNL N/A
Recruiting NCT01514032 - Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones N/A
Completed NCT00873054 - Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy N/A
Completed NCT00765128 - Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy Phase 4
Withdrawn NCT00583258 - A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones N/A
Active, not recruiting NCT03630926 - Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.
Not yet recruiting NCT02214836 - Ultrasound Imaging of Kidney Stones and Lithotripsy N/A
Completed NCT03095885 - A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria N/A
Completed NCT01088555 - Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers N/A
Completed NCT01330940 - Effect of Diet Orange Soda on Urinary Lithogenicity N/A
Recruiting NCT00489723 - Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ? N/A
Recruiting NCT05417568 - Oxalate-Driven Host Responses in Kidney Stone Disease N/A
Recruiting NCT02375295 - Struvite Stones Antibiotic Study Phase 4
Enrolling by invitation NCT02408211 - Preoperative Antibiotic PNL Study Phase 4
Withdrawn NCT01560091 - Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy Phase 3