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

Sponsored by:	Omeros Corporation
Information provided by:	Omeros Corporation
ClinicalTrials.gov Identifier:	NCT00857090

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: Surgery

U.S. FDA Resources

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 ]

Estimated Enrollment:	36
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 Stage 3: OMS201 irrigation solution ranging between 1X (base concentration) and 10X the base concentration during surgery. The concentration chosen will be based on analysis of data from prior stages.
2: Placebo Comparator Vehicle	Drug: Vehicle Stages 1-3: 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

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

Contacts

Contact: Gregory Demopulos, M.D., CMO, CEO

206-676-5000

Locations

United States, California
University of California Irvine Medical Center	Recruiting
Orange, California, United States, 92868
Contact: Rosanne Santos 714-456-8176 rtsantos@uci.edu
Principal Investigator: Elspeth McDougall, M.D.
United States, Texas
UT Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: Beth Petty 214-645-8787 Beth.Petty@UTSouthwestern.edu
Principal Investigator: Margaret Pearle, M.D.

Sponsors and Collaborators

Omeros Corporation

More Information

No publications provided

Responsible Party:	Omeros Corporation ( Gregory Demopulos, M.D., CMO, CEO )
Study ID Numbers:	C08-001
Study First Received:	March 4, 2009
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00857090 History of Changes
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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis

Kidney Diseases
Calculi
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis

Kidney Diseases
Calculi
Nephrolithiasis
Kidney Calculi

ClinicalTrials.gov processed this record on September 10, 2009