Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication
NCT ID: NCT00725881
Last Updated: 2011-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2008-08-31
2010-03-31
Brief Summary
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Detailed Description
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This double-blinded, placebo-controlled clinical trial will randomize up to 48 patients at up to 8 clinical research sites in the US. In addition to safety and pharmacokinetic assessments conducted during the trial, the primary endpoint of the study will be demonstrated from standardized, graded exercise treadmill tests conducted throughout the study. The clearly measurable parameters will be peak walking time (PWT) and claudication onset time (COT) comparing baseline and after TSC or placebo and are well-established endpoints accepted by the medical community and regulatory authorities for IC clinical trials.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
.25 mg/kg TSC
Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
2
.5 mg/kg TSC
Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
3
.75 mg/kg TSC
Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
4
1.0 mg/kg TSC
Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
5
1.25 mg/kg TSC
Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
6
1.5 mg/kg TSC
Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
7
1.75 mg/kg TSC
Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
8
2.0 mg/kg TSC
Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
9
5.0 mL 0.9% normal saline
0.9% normal saline
A total volume of 5.0 mL normal saline will be dosed in a superficial vein of the arm via syringe over a period of up to 2 minutes.
Interventions
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Trans sodium crocetinate (TSC)
Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days
0.9% normal saline
A total volume of 5.0 mL normal saline will be dosed in a superficial vein of the arm via syringe over a period of up to 2 minutes.
Eligibility Criteria
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Inclusion Criteria
* 6-mo. history of walking limitation or symptoms of intermittent claudication (IC) in at least 1 lower limb, severity of which has not changed in the past 3 mo. and diagnosed by principal investigator as clinically stable Fontaine Stage II peripheral artery disease (PAD)
* Diagnosis of PAD secondary to atherosclerosis
* If ankle-brachial index (ABI) is \> 1.3 or cannot be measured in either leg, vascular etiology documented by toe-brachial index (TBI) ≤ 0.7 in at least 1 leg
* Claudication severity, meds. for the treatment of coronary artery disease (CAD), PAD and IC, and exercise habits should be clinically stable for 3 mo. prior to Screening (SCRN) and during study. Pt. is not likely to change smoking and/or exercise habits during study
* On an exercise treadmill test (ETT), peak walking time (PWT) of at least 1 min., but no more than 12 min. at Baseline
* Willing and able to discontinue Pletal or Trental for 21 days before SCRN and during study
* Antihypertensive therapy, cholesterol-lowering therapy, chronic oral nitrates, and diabetic therapy have been stable for 30 days prior to SCRN
* Willing and able to provide written, signed, informed consent after the nature of the study has been explained and prior to any research-related procedures
* Willing and able to comply with all study-related procedures
* Sexually active patients must use an acceptable method of contraception while participating in the study
* Females of childbearing potential must have a negative pregnancy test at SCRN and have additional pregnancy tests during the study
Exclusion Criteria
* Current or history of critical limb ischemia (CLI)
* Pts. in whom artery insufficiency in the lower extremity is the result of acute limb ischemia (ALI) or an immunological or inflammatory non-atherosclerotic disorder
* Pts. in whom walking impairment due to pain is the result of other non-atherosclerotic co-morbid conditions
* A surgical intervention to alleviate symptoms of IC or PAD-specific endovascular intervention or cardiovascular surgery within 3 mo. of SCRN
* Walking limited by reasons other than claudication
* Conditions other than IC of significant severity that could confound PWT on the ETT
* Concurrent severe congestive heart failure (CHF)
* Life-threatening ventricular arrhythmias, unstable angina, and/or myocardial infarction (MI) within 3 mo. before enrollment (ENRL)
* Coronary artery bypass grafting or percutaneous coronary intervention within 4 mo. before ENRL
* Renal and/or carotid revascularization procedure within 3 mo. of ENRL
* Transient ischemic attack (TIA) within 3 mo. before ENRL
* Deep vein thrombosis (DVT) within 3 mo. before ENRL
* Severe chronic obstructive pulmonary disease (COPD)
* Thrombocytopenia
* Undergoing hemodialysis or peritoneal dialysis
* Pts. w/immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy
* Neurological dementia
* Stroke
* Clinically significant electrocardiogram (ECG) change during or after ETT at SCRN or Baseline visit(s)
* Cerebrovascular infarct within 3 mo. of SCRN
* Poorly controlled type 1 or type 2 diabetes at SCRN
* History of migraine headaches within last 12 mo.
* Patients with clinically significant abnormal hematology labs or blood chemistry labs
* Body mass index \> 35
* Hypertension at SCRN defined as resting BP values of \> 170 mmHg systolic and/or \> 110 mmHg diastolic
* Hypotension at SCRN defined as resting BP values \< 100 mmHg systolic or \< 55 mmHg diastolic or symptomatic hypotension
* Previous treatment with any formulation of TSC
* Known allergy or hypersensitivity to any excipient (gamma-cyclodextrin, mannitol, glycine) of TSC formulation
* Previous treatment with gene therapy or other VEGF-related treatment within 12 mo. of SCRN
* Patients with recent history of alcoholism or drug abuse, or severe emotional, behavioral, or psychiatric problems
* Patients receiving experimental medications or participating in other study using an experimental drug or procedure within 45 days prior to ENRL
40 Years
ALL
No
Sponsors
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Diffusion Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Diffusion Pharmaceuticals LLC
Locations
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Cardiology, P.C.
Birmingham, Alabama, United States
Radiant Research, Inc.
Santa Rosa, California, United States
Stanford University School of Medicine, Division of Cardiovascular Medicine
Stanford, California, United States
Andrews Research and Education
Pensacola, Florida, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Countries
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References
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Mohler ER 3rd, Gainer JL, Whitten K, Eraso LH, Thanaporn PK, Bauer T. Evaluation of trans sodium crocetinate on safety and exercise performance in patients with peripheral artery disease and intermittent claudication. Vasc Med. 2011 Oct;16(5):346-53. doi: 10.1177/1358863X11422742.
Other Identifiers
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DP100-301
Identifier Type: -
Identifier Source: org_study_id