IMX-150 Cream for Diabetic Neuropathy

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Drug: IMX-150; Drug: IMX-150; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; 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; Drug: IMX-150; (0.6%) 0.5g topically BID to each foot for 4 weeks
Experimental: B; IMX-150(0.6%) 0.5 g topically BID to each foot	Drug: IMX-150; (0.3%) 0.5g topically BID to each foot for 4 weeks; Drug: IMX-150; (0.6%) 0.5g topically BID to each foot for 4 weeks
Placebo Comparator: C; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores	Weekly average of "24-hour Average Pain"

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in weekly average sleep disturbance	daily

Collaborators and Investigators

• Sponsor: Procris Pharmaceuticals
• Investigators: Study Director: Patrick Yeramian, MD, VP Medical Affairs

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: March 17, 2008
• First Submitted That Met QC Criteria: March 21, 2008
• First Posted (Estimate): March 24, 2008

Study Record Updates

• Last Update Posted (Estimate): June 17, 2008
• Last Update Submitted That Met QC Criteria: June 13, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Foot Pain; Diabetic Neuropathy Pain; Diabetic Peripheral Neuropathy foot pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: 01-004A