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

Critical Limb Ischemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00445159
• Other study ID #: UT-15C
• Status: Recruiting
• Phase: Phase 2
• First received: March 7, 2007
• Last updated: March 7, 2007
• Start date: November 2006

Study information

• Verified date: March 2007
• Source: Southern Arizona Vascular Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Have been taking analgesics to control ischemic rest pain for at least two weeks at Baseline.

3. Have signed an appropriate consent for participation in this study.

4. If female, be physiologically incapable of childbearing or practicing acceptable methods of birth c

Exclusion Criteria:

1. Have had a vascular surgery or other vascular procedure to treat their CLI within 30 days prior to study entry.

2. Have a planned or scheduled vascular surgery or endovascular procedure.

3. Be currently taking any investigational drugs for CLI.

4. Have received prostaglandins such as PGE1, epoprostenol (Flolan®), or any other prostacyclin (PGI2) or prostacyclin analog in the past 30 days.

5. Be hemodynamically unstable or have acute renal failure, cardiac failure or pulmonary failure.

6. Have a diagnosis of Stage IVb (Fontaine) or Stage 6 (Rutherford scale) Critical Limb Ischemia due to documented peripheral arterial disease

7. Have an unhealed incision(s) from a toe or transmetatarsal amputation at Baseline.

8. Have any wound with significant gangrene or exposed tendons.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Drug:
• UT-15C SR (treprostinil diethanolamine) 1mg oral tablets

Locations

Country	Name	City	State
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Southern Arizona Vascular Institute	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Southern Arizona Vascular Institute	Southern Illinois University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain
Secondary	To assess the effect of UT-15C on the following disease symptoms associated with CLI:
Secondary	ž Ischemic rest pain
Secondary	ž Sleep interference
Secondary	ž Ambulatory status
Secondary	ž Ischemic wound healing (if applicable)
Secondary	To obtain peak and trough treprostinil plasma levels in CLI subjects