Clinical trial NCT00641953: IMX-150 Cream for Diabetic Neuropathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathy
Keywords: Foot Pain
Diabetic Neuropathy Pain
Diabetic Peripheral Neuropathy foot pain
Lead sponsor: Procris Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores
timeFrame: Weekly average of "24-hour Average Pain"
Secondary outcomes:
measure: Change in weekly average sleep disturbance
timeFrame: daily
Other outcomes:
Locations:
city: Brooksville
country: United States
facility: Meriden Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research
state: Florida
city: Oviedo
country: United States
facility: Alpha Medical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
Study officials:
affiliation: VP Medical Affairs
name: Patrick Yeramian, MD
role: STUDY_DIRECTOR
References: