IMX-150 Cream for Diabetic Neuropathy

NCT00641953 | Completed Phase 2

• 1 other identifier: 01-004A
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 7

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Foot Pain; Diabetic Neuropathy Pain; Diabetic Peripheral Neuropathy foot pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in weekly average sleep disturbance

  daily

Study Arms (3)

A

EXPERIMENTAL

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

Drug: IMX-150

B

EXPERIMENTAL

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

Drug: IMX-150

C

PLACEBO COMPARATOR

Placebo 0.5 g topically BID to each foot for 4 weeks

Drug: Placebo

Interventions

IMX-150 DRUG

(0.3%) 0.5g topically BID to each foot for 4 weeks

A

Placebo DRUG

0.5 g topically BID to each foot for 4 weeks

C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Procris Pharmaceuticals: lead

Study Sites (7)

Meriden Research

Brooksville, Florida, 34613, United States

Location

Health Awareness

Jupiter, Florida, 33458, United States

Location

International Research Associates, LLC

Miami, Florida, 33156, United States

Location

Peninsula Research

Ormond Beach, Florida, 32174, United States

Location

Alpha Medical Research

Oviedo, Florida, 32765, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Hampton Roads Center for Clinical Research

Norfolk, Virginia, 23502, United States

Location

Study Officials

• Patrick Yeramian, MD

  VP Medical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 17, 2008

Record last verified: 2008-06

Locations

US (7)