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IMX-150 Cream for Diabetic Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IMX-150
IMX-150
Placebo
Sponsored by
Procris Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring Foot Pain, Diabetic Neuropathy Pain, Diabetic Peripheral Neuropathy foot pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Meriden Research
  • Health Awareness
  • International Research Associates, LLC
  • Peninsula Research
  • Alpha Medical Research
  • Meridien Research
  • Hampton Roads Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

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

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

Placebo 0.5 g topically BID to each foot for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in weekly average sleep disturbance

Full Information

First Posted
March 17, 2008
Last Updated
June 13, 2008
Sponsor
Procris Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00641953
Brief Title
IMX-150 Cream for Diabetic Neuropathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Procris Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
Foot Pain, Diabetic Neuropathy Pain, Diabetic Peripheral Neuropathy foot pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
IMX-150 (0.3%) 0.5 g topically BID each foot
Arm Title
B
Arm Type
Experimental
Arm Description
IMX-150(0.6%) 0.5 g topically BID to each foot
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Placebo 0.5 g topically BID to each foot for 4 weeks
Intervention Type
Drug
Intervention Name(s)
IMX-150
Intervention Description
(0.3%) 0.5g topically BID to each foot for 4 weeks
Intervention Type
Drug
Intervention Name(s)
IMX-150
Intervention Description
(0.6%) 0.5g topically BID to each foot for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.5 g topically BID to each foot for 4 weeks
Primary Outcome Measure Information:
Title
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"
Secondary Outcome Measure Information:
Title
Change in weekly average sleep disturbance
Time Frame
daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Yeramian, MD
Organizational Affiliation
VP Medical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Meriden Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Health Awareness
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Peninsula Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Alpha Medical Research
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Hampton Roads Center for Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

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IMX-150 Cream for Diabetic Neuropathy

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