Clinical Trials Logo

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
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 NCT00765128 - Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy Phase 4
Completed NCT00873054 - Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy N/A
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 NCT01330940 - Effect of Diet Orange Soda on Urinary Lithogenicity N/A
Completed NCT01088555 - Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers 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