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A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy

Primary Purpose

Painful Diabetic Neuropathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SKL11197
Placebo
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years or older
  2. Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
  3. At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);
  4. HbA1c < 12 % at Screening
  5. Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
  6. Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral.
  7. Females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, Menopause is defined as 1 year since last menstrual period with associated subjective sensations), or,
  8. If capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. Females capable of bearing children must have negative serum pregnancy (beta-HCG) test at Screening and negative urine pregnancy on Day 1.

Exclusion Criteria:

  1. Pregnant or lactating females
  2. Subjects with BMI over 40
  3. Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication)
  4. Subjects with known clinically significant decreased blood flow to the extremities
  5. Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain
  6. Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;
  7. Have profound autonomic dysfunction, or brittle diabetes;
  8. Evidence of amputations (including toes), open ulcers, or Charcot joint.

Sites / Locations

  • Neurology Clinic, P.C.
  • Principals Research Group
  • Clinical Trials, Inc.
  • Collaborative Neuroscience Network, Inc.
  • Neurological Research Institute
  • Renstar Medical Research
  • Comprehensive Clinical Development
  • Clinical Research of West Florida, Inc.
  • International Clinical Research Institute
  • Michigan Head Pain & Neurological Institute.
  • Creighton Diabetes Center
  • Sunstone Medical Research, LLC
  • Nerve and Muscle Center of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SKL11197

Placebo

Arm Description

This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.

This arm is the placebo comparator arm. Patients will be randomized to this arm.

Outcomes

Primary Outcome Measures

Relief of diabetic neuropathy pain

Secondary Outcome Measures

Average daily pain score

Full Information

First Posted
January 26, 2012
Last Updated
May 18, 2015
Sponsor
SK Life Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01521598
Brief Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic peripheral neuropathy pain (DPN). Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with painful diabetic peripheral neuropathy. Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit from the double-blind phase because of inadequate pain relief.
Detailed Description
This study is a double-blind, placebo controlled study with three phases; a pre-study medication washout/screening phase upto 3 weeks a 3-week, open label phase a 6-week double-blind phase At the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria. Eligible subjects will be randomized in a blinded fashion either to continue with SKL11197 at 300 mg TID or to take the same number of placebo capsules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
Keywords
Diabetic Peripheral Neuropathy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SKL11197
Arm Type
Experimental
Arm Description
This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm is the placebo comparator arm. Patients will be randomized to this arm.
Intervention Type
Drug
Intervention Name(s)
SKL11197
Intervention Description
SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
This is the placebo. Patients will be randomized the placebo.
Primary Outcome Measure Information:
Title
Relief of diabetic neuropathy pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Average daily pain score
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic); HbA1c < 12 % at Screening Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy. Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral. Females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, Menopause is defined as 1 year since last menstrual period with associated subjective sensations), or, If capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. Females capable of bearing children must have negative serum pregnancy (beta-HCG) test at Screening and negative urine pregnancy on Day 1. Exclusion Criteria: Pregnant or lactating females Subjects with BMI over 40 Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication) Subjects with known clinically significant decreased blood flow to the extremities Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure; Have profound autonomic dysfunction, or brittle diabetes; Evidence of amputations (including toes), open ulcers, or Charcot joint.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Kamin, M.D.
Organizational Affiliation
SKLSI (Sponsor)
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Clinic, P.C.
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
Principals Research Group
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71901
Country
United States
Facility Name
Clinical Trials, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
33471
Country
United States
Facility Name
Comprehensive Clinical Development
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
International Clinical Research Institute
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Michigan Head Pain & Neurological Institute.
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Nerve and Muscle Center of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy

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