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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT00857090
First received: March 4, 2009
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Urinary Calculi
Urinary Stones
Urinary Tract Stones
Renal Calculi
Kidney Stones
Drug: OMS201
Drug: Vehicle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Omeros Corporation:

Primary Outcome Measures:
  • Peak systemic exposure. [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Degree of pain [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Duration of the operation [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • Ease of placement of the ureteral access sheath [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug
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

Placebo Comparator: 2
Vehicle
Drug: Vehicle
Stages 1-2: Vehicle irrigation solution during surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857090

Locations
United States, California
University of California Irvine Medical Center
Orange, California, United States, 92868
United States, Colorado
Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Tennessee
Urology Associates
Nasville, Tennessee, United States, 37209
United States, Texas
Urology San Antonio Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Omeros Corporation
  More Information

No publications provided

Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT00857090     History of Changes
Other Study ID Numbers: C08-001
Study First Received: March 4, 2009
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Omeros Corporation:
Urinary Calculi
Urinary Stones
Urinary Tract Stones
Renal Calculi
Kidney Stones
Calculi
Urolithotomy
Ureteroscopy

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Urinary Calculi
Kidney Diseases
Pathological Conditions, Anatomical
Urolithiasis
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014