UT-15C SR in the Treatment of Critical Limb Ischemia - Full Text View

Purpose

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

Condition	Intervention	Phase
Critical Limb Ischemia	Drug: UT-15C SR (treprostinil diethanolamine) 1mg oral tablets	Phase II

Drug Information available for:

U 62840 Diethanolamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	An Investigator Initiated Eight Week Two Center Open-Label Pilot Study of the Tolerability and Safety of Oral UT-15C (Treprostinil Diethanolamine)SR Tablets in Patients With Critical Limb Ischemia (CLI) and Ischemic Rest Pain

Further study details as provided by Southern Arizona Vascular Institute:

Primary Outcome Measures:

To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain

Secondary Outcome Measures:

To assess the effect of UT-15C on the following disease symptoms associated with CLI:
ž Ischemic rest pain
ž Sleep interference
ž Ambulatory status
ž Ischemic wound healing (if applicable)
To obtain peak and trough treprostinil plasma levels in CLI subjects

Estimated Enrollment:	20
Study Start Date:	November 2006

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 4mg/day .

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 mg/day .

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have an ankle systolic pressure ≤ 60 mm/Hg OR ABI ≤ 0.60 OR toe systolic pressure ≤ 60 mm/Hg OR an arteriogram showing at least one level of occlusion of lower extremity arteries.
Have been taking analgesics to control ischemic rest pain for at least two weeks at Baseline.
Have signed an appropriate consent for participation in this study.
If female, be physiologically incapable of childbearing or practicing acceptable methods of birth c

Exclusion Criteria:

Have had a vascular surgery or other vascular procedure to treat their CLI within 30 days prior to study entry.
Have a planned or scheduled vascular surgery or endovascular procedure.
Be currently taking any investigational drugs for CLI.
Have received prostaglandins such as PGE1, epoprostenol (Flolan®), or any other prostacyclin (PGI2) or prostacyclin analog in the past 30 days.
Be hemodynamically unstable or have acute renal failure, cardiac failure or pulmonary failure.
Have a diagnosis of Stage IVb (Fontaine) or Stage 6 (Rutherford scale) Critical Limb Ischemia due to documented peripheral arterial disease
Have an unhealed incision(s) from a toe or transmetatarsal amputation at Baseline.
Have any wound with significant gangrene or exposed tendons.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445159

Locations


United States, Arizona
	Southern Arizona Vascular Institute	Recruiting
	Tucson, Arizona, United States, 85704
	Contact: Sonia Voigt, RN 520-297-5846 svoigt@azvasc.com
	Principal Investigator: Scott S Berman, MD

United States, Illinois
	Southern Illinois University School of Medicine	Recruiting
	Springfield, Illinois, United States, 62794-9638
	Contact: Carol Buettner 217-545-2320 cbuettner@siumed.edu
	Principal Investigator: Colleen Johnson, MD

Sponsors and Collaborators

Southern Arizona Vascular Institute

Southern Illinois University

Investigators


Principal Investigator:	Colleen Johnson, MD	Southern Illinois University

Principal Investigator:	Scott S Berman, MD	Southern Arizona Vascular Institute

More Information

Study ID Numbers:	UT-15C
First Received:	March 7, 2007
Last Updated:	March 7, 2007
ClinicalTrials.gov Identifier:	NCT00445159
Health Authority:	United States: Food and Drug Administration

Keywords provided by Southern Arizona Vascular Institute:

UT-15C SR, Peripheral Vascular Disease, treprostinil

Study placed in the following topic categories:

Peripheral Vascular Diseases

Treprostinil

Vascular Diseases

Pain

Ischemia

Additional relevant MeSH terms:

Pathologic Processes

Therapeutic Uses

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	Southern Arizona Vascular Institute Southern Illinois University
Information provided by:	Southern Arizona Vascular Institute
ClinicalTrials.gov Identifier:	NCT00445159