NCT00857090

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

March 4, 2009

Last Update Submit

October 10, 2012

Conditions

Urinary CalculiUrinary StonesUrinary Tract StonesRenal CalculiKidney Stones

Keywords

Urinary CalculiUrinary StonesUrinary Tract StonesRenal CalculiKidney StonesCalculiUrolithotomyUreteroscopy

Outcome Measures

Primary Outcomes (1)

  • Peak systemic exposure.

    Day of surgery

Secondary Outcomes (4)

  • Safety

    Day 7

  • Degree of pain

    7 days

  • Duration of the operation

    Day of surgery

  • Ease of placement of the ureteral access sheath

    Day of surgery

Study Arms (2)

1

EXPERIMENTAL

Drug

Drug: OMS201

2

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

Interventions

OMS201DRUG

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

1
VehicleDRUG

Stages 1-2: Vehicle irrigation solution during surgery

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age.
  • Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Urology Associates

Nasville, Tennessee, 37209, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Urinary CalculiKidney CalculiCalculi

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNephrolithiasisKidney Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

US(4)