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
UT-15C SR in the Treatment of Critical Limb Ischemia
Sponsors
Source
Southern Arizona Vascular Institute
Oversight Info
Has Dmc
Yes
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 .
Overall Status
Unknown status
Start Date
2006-11-01
Completion Date
N/A
Primary Completion Date
N/A
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
|
To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain |
Secondary Outcome
Measure |
|
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 |
Enrollment
20
Condition
Intervention
Eligibility
Criteria
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.
Gender
All
Minimum Age
45 Years
Maximum Age
85 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Colleen Johnson, MD |
Principal Investigator |
Southern Illinois University |
|
Scott S Berman, MD |
Principal Investigator |
Southern Arizona Vascular Institute |
Location
Facility |
Status |
Contact |
Investigator |
|
Southern Arizona Vascular Institute Tucson Arizona 85704 United States |
Recruiting |
Last Name: Scott S Berman, MD Role: Principal Investigator | |
|
Southern Illinois University School of Medicine Springfield Illinois 62794-9638 United States |
Recruiting |
Last Name: Colleen Johnson, MD Role: Principal Investigator |
Location Countries
Country
United States
Verification Date
2007-03-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keyword
Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Treprostinil
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)
Study First Submitted
March 7, 2007
Study First Submitted Qc
March 7, 2007
Study First Posted
March 8, 2007
Last Update Submitted
March 7, 2007
Last Update Submitted Qc
March 7, 2007
Last Update Posted
March 8, 2007
Last Known Status
Recruiting
ClinicalTrials.gov processed this data on August 31, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.