IMX-150 Cream for Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Procris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00641953
First received: March 17, 2008
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Diabetic Peripheral Neuropathy
Drug: IMX-150
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Procris Pharmaceuticals:

Primary Outcome Measures:
  • Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores [ Time Frame: Weekly average of "24-hour Average Pain" ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in weekly average sleep disturbance [ Time Frame: daily ] [ Designated as safety issue: No ]

Enrollment: 155
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: B
IMX-150(0.6%) 0.5 g topically BID to each foot
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641953

Locations
United States, Florida
Meriden Research
Brooksville, Florida, United States, 34613
Health Awareness
Jupiter, Florida, United States, 33458
International Research Associates, LLC
Miami, Florida, United States, 33156
Peninsula Research
Ormond Beach, Florida, United States, 32174
Alpha Medical Research
Oviedo, Florida, United States, 32765
Meridien Research
Saint Petersburg, Florida, United States, 33709
United States, Virginia
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Procris Pharmaceuticals
Investigators
Study Director: Patrick Yeramian, MD VP Medical Affairs
  More Information

No publications provided

Responsible Party: Matthew A. Gonda, PhD, Procris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00641953     History of Changes
Other Study ID Numbers: 01-004A
Study First Received: March 17, 2008
Last Updated: June 13, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Procris Pharmaceuticals:
Foot Pain
Diabetic Neuropathy Pain
Diabetic Peripheral Neuropathy foot pain

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014