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
PHASE2
155 participants
INTERVENTIONAL
2007-08-31
2008-03-31
Brief Summary
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Detailed Description
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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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A
IMX-150 (0.3%) 0.5 g topically BID each foot
IMX-150
(0.3%) 0.5g topically BID to each foot for 4 weeks
B
IMX-150(0.6%) 0.5 g topically BID to each foot
IMX-150
(0.6%) 0.5g topically BID to each foot for 4 weeks
C
Placebo 0.5 g topically BID to each foot for 4 weeks
Placebo
0.5 g topically BID to each foot for 4 weeks
Interventions
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IMX-150
(0.3%) 0.5g topically BID to each foot for 4 weeks
IMX-150
(0.6%) 0.5g topically BID to each foot for 4 weeks
Placebo
0.5 g topically BID to each foot for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* If female, may not be pregnant or lactating
* Can be treated on an outpatient basis
* Has a clinical diagnosis of Type-1 or Type II diabetes with: confirmed diagnosis of diabetic distal symmetrical sensorimotor polyneuropathy and bilateral pain in the feet for at least 3 months.
* Must have a hemoglobin A1C value of 11% or less that is stable under treatment
* Agrees to use the test creams as specified for the 4 week period
* Willing to not use any other medications, including investigational medications, to treat pain symptoms of Diabetic Neuropathy while in study.
Exclusion Criteria
* Currently using Viagra®, Levitra®, Cialis® or other phosphodiesterase 5 inhibitors medications for erectile dysfunction
* Currently treated for symptoms of diabetic neuropathy, including but not limited to Lyrica®, Cymbalta® and transcutaneous stimulation
* Not on a stable dose for at least 4 weeks prior to study screening of other vasodilators required for underlying conditions
* Know allergy to Nitroglycerin, propylene glycol or common moisturizing creams
* History of migraine, cluster or vascular headaches, chronic pain with greater pain intensity than the pain of diabetic neuropathy or other chronic pain condition within the region of the diabetic peripheral neuropathy
* Amputation of more than one toe per foot
* Neurological disorder or skin condition that may alter local sensation in the feet
* History of unstable medical problem, clinically significant screening laboratory test or any current medical condition that would contraindicate the administration of the study mediation, interfere with the study evaluations, or interfere with the patient's ability to comply with the study
* History of drug (including cannabinoid) or alcohol abuse within the past year
* Cognitive or language difficulties that would impair completion of the pain assessment tool
* Within the past 3 months, have had either a myocardial infarction, uncontrolled hypotension, or uncontrolled hypertension
* Participated in a study of any investigational drug within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to Screening
* Major abdominal, thoracic or vascular surgery within 6 months of the first dose of study medication
* Open lesions in the area where the cream is to be applied
* Fertile patients who are unable or unwilling to comply with the contraceptive requirements during the study period
18 Years
75 Years
ALL
No
Sponsors
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Procris Pharmaceuticals
INDUSTRY
Responsible Party
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Procris Pharmaceuticals
Principal Investigators
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Patrick Yeramian, MD
Role: STUDY_DIRECTOR
VP Medical Affairs
Locations
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Meriden Research
Brooksville, Florida, United States
Health Awareness
Jupiter, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Peninsula Research
Ormond Beach, Florida, United States
Alpha Medical Research
Oviedo, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States
Countries
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Other Identifiers
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01-004A
Identifier Type: -
Identifier Source: org_study_id