IMX-150 Cream for Diabetic Neuropathy

Procris Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: IMX-150; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641953

01-004A

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

IMX-150 (0.3%) 0.5 g topically BID each foot

Treatment:

Drug: IMX-150

Drug: IMX-150

B

Experimental group

Description:

IMX-150(0.6%) 0.5 g topically BID to each foot

Treatment:

Drug: IMX-150

Drug: IMX-150

C

Placebo Comparator group

Description:

Placebo 0.5 g topically BID to each foot for 4 weeks

Treatment:

Drug: Placebo