Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445159
Status:
UNKNOWN
Last Update Posted:
2007-03-08
First Post:
2007-03-07
Brief Title:
UT-15C SR in the Treatment of Critical Limb Ischemia
Sponsor:
Southern Arizona Vascular Institute
Organization:
Southern Arizona Vascular Institute
Study Overview
Official Title:
An Investigator Initiated Eight Week Two Center Open-Label Pilot Study of the Tolerability and Safety of Oral UT-15C Treprostinil DiethanolamineSR Tablets in Patients With Critical Limb Ischemia CLI and Ischemic Rest Pain
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic lower limb rest pain related to advanced peripheral arterial disease Rest pain is one of the primary management issues of severe arterial occlusive disease and may lead to amputation when the pain becomes intolerable and unresponsive to narcotic analgesia Rest pain also impacts the quality of sleep and mobility with frequent interruptions in sleep and decreased mobility Treprostinil sodium Remodulin has been studies in several small open-label studies and has been shown to be safe as well as an effective agent for ischemic rest pain when given by subcutaneous or intravenous delivery However these forms of administration have patient convenience limitations including the need for an infusion device and associated pain at the site of infusion with subcutaneous delivery UT-15C may allow patients suffering from CLI to benefit from the simplicity of an oral dosage form
Detailed Description:
This study is an eight week two center open-label study assessing the tolerability safety and efficacy of oral UT-15C sustained release tablets in subjects with CLI and ischemic lower limb rest pain with or without an ischemic wound present Conventional therapy should be continued without changes over the course of the study for all subjects
Group 1 The first ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg The dose will be titrated upward every seven days depending on tolerability to a maximum dose of 4mgday
Group 2 The last ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg The dose will be titrated upward every seven days depending on tolerability to a maximum dose of 8 mgday
Group 1 The first ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg The dose will be titrated upward every seven days depending on tolerability to a maximum dose of 4mgday
Group 2 The last ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg The dose will be titrated upward every seven days depending on tolerability to a maximum dose of 8 mgday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None