IMX-150 Cream for Diabetic Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641953
• Other study ID #: 01-004A
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2008
• Last updated: June 13, 2008
• Start date: August 2007
• Est. completion date: March 2008

Study information

• Verified date: June 2008
• Source: Procris Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Meriden Research	Brooksville	Florida
United States	Health Awareness	Jupiter	Florida
United States	International Research Associates, LLC	Miami	Florida
United States	Hampton Roads Center for Clinical Research	Norfolk	Virginia
United States	Peninsula Research	Ormond Beach	Florida
United States	Alpha Medical Research	Oviedo	Florida
United States	Meridien Research	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Procris Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	No
Secondary	Change in weekly average sleep disturbance		daily	No