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

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ClinicalTrials.gov Identifier: NCT00445159
Recruitment Status : Unknown
Verified March 2007 by Southern Arizona Vascular Institute.
Recruitment status was:  Recruiting
First Posted : March 8, 2007
Last Update Posted : March 8, 2007
Sponsor:
Collaborator:
Southern Illinois University
Information provided by:
Southern Arizona Vascular Institute

Tracking Information
First Submitted Date  ICMJE March 7, 2007
First Posted Date  ICMJE March 8, 2007
Last Update Posted Date March 8, 2007
Study Start Date  ICMJE November 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2007)
To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UT-15C SR in the Treatment of Critical Limb Ischemia
Official Title  ICMJE 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
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 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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Critical Limb Ischemia
Intervention  ICMJE Drug: UT-15C SR (treprostinil diethanolamine) 1mg oral tablets
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: March 7, 2007)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00445159
Other Study ID Numbers  ICMJE UT-15C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Southern Arizona Vascular Institute
Collaborators  ICMJE Southern Illinois University
Investigators  ICMJE
Principal Investigator: Colleen Johnson, MD Southern Illinois University
Principal Investigator: Scott S Berman, MD Southern Arizona Vascular Institute
PRS Account Southern Arizona Vascular Institute
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP