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| Sponsor: | Omeros Corporation |
|---|---|
| Information provided by: | Omeros Corporation |
| ClinicalTrials.gov Identifier: | NCT00599664 |
Purpose
Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Calculi Urinary Stones Urinary Tract Stones |
Drug: OMS201 Drug: Vehicle |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-Blind, Placebo-Controlled, Two-Center, Pharmacokinetic Study Evaluating the Systemic Absorption and Safety of OMS201 in Subjects Undergoing Ureteroscopic Treatment of Unilateral Ureteral- or Renal Collecting System-Located Stones |
| Enrollment: | 11 |
| Study Start Date: | December 2007 |
| Study Completion Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Drug
|
Drug: OMS201
OMS201 irrigation solution during surgery
|
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Placebo Comparator: 2
Vehicle
|
Drug: Vehicle
Vehicle irrigation solution during surgery
|
OMS201 is being developed to facilitate endoscopy of the ureters and to reduce postoperative discomfort, such as pain, frequency, urgency and/or difficult urination following endoscopic surgery to remove a urinary tract stone.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UC Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| United States, Texas | |
| University of Texas Southwestern | |
| Dallas, Texas, United States, 75390 | |
| Study Director: | Scott Houston | Omeros Corporation |
More Information
| Responsible Party: | Gregory Demopulos, MD, CMO, CEO, Omeros Corporation |
| ClinicalTrials.gov Identifier: | NCT00599664 History of Changes |
| Other Study ID Numbers: | C07-001 |
| Study First Received: | December 26, 2007 |
| Last Updated: | April 28, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Urinary Calculi Urinary Stones Urinary Tract Stones Calculi |
|
Calculi Urinary Calculi Pathological Conditions, Anatomical Urolithiasis Urologic Diseases |