IMX-150 Cream for Diabetic Neuropathy - Full Text View

Sponsored by:	Procris Pharmaceuticals
Information provided by:	Procris Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00641953

Purpose

The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the feet.

Condition	Intervention	Phase
Diabetic Peripheral Neuropathy	Drug: IMX-150 Drug: Placebo	Phase II

MedlinePlus related topics: Diabetic Nerve Problems Foot Health Peripheral Nerve Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Phase II, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response Study of an Aqueous Topical Formulation of Nitroglycerin, IMX-150, in the Treatment of Pain in Diabetic Peripheral Neuropathy of the Feet

Further study details as provided by Procris Pharmaceuticals:

Primary Outcome Measures:

Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores [ Time Frame: Weekly average of "24-hour Average Pain" ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in weekly average sleep disturbance [ Time Frame: daily ] [ Designated as safety issue: No ]

Enrollment:	155
Study Start Date:	August 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental IMX-150 (0.3%) 0.5 g topically BID each foot	Drug: IMX-150 (0.3%) 0.5g topically BID to each foot for 4 weeks
B: Experimental IMX-150(0.6%) 0.5 g topically BID to each foot	Drug: IMX-150 (0.6%) 0.5g topically BID to each foot for 4 weeks
C: Placebo Comparator Placebo 0.5 g topically BID to each foot for 4 weeks	Drug: Placebo 0.5 g topically BID to each foot for 4 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have sufficient command and understanding of the English language to complete diaries and questionnaires
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 any nitrate medications
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641953

Locations

United States, Florida
Peninsula Research
Ormond Beach, Florida, United States, 32174
Health Awareness
Jupiter, Florida, United States, 33458
Meriden Research
Brooksville, Florida, United States, 34613
Meridien Research
Saint Petersburg, Florida, United States, 33709
Alpha Medical Research
Oviedo, Florida, United States, 32765
International Research Associates, LLC
Miami, Florida, United States, 33156
United States, Virginia
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502

Sponsors and Collaborators

Procris Pharmaceuticals

Investigators

Study Director:

Patrick Yeramian, MD

VP Medical Affairs

More Information

No publications provided

Responsible Party:	Procris Pharmaceuticals ( Matthew A. Gonda, PhD )
Study ID Numbers:	01-004A
Study First Received:	March 17, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00641953 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procris Pharmaceuticals:

Foot Pain
Diabetic Neuropathy Pain
Diabetic Peripheral Neuropathy foot pain

Study placed in the following topic categories:

Nitroglycerin
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases

Diabetes Mellitus
Endocrine System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on May 06, 2009