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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01521598
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : June 11, 2015
Information provided by (Responsible Party):
SK Life Science, Inc.

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.

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Drug: SKL11197 Drug: Placebo Phase 2

Detailed Description:

This study is a double-blind, placebo controlled study with three phases;

  1. a pre-study medication washout/screening phase upto 3 weeks
  2. a 3-week, open label phase
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SKL11197
This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.
Drug: SKL11197
SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.

Placebo Comparator: Placebo
This arm is the placebo comparator arm. Patients will be randomized to this arm.
Drug: Placebo
This is the placebo. Patients will be randomized the placebo.

Primary Outcome Measures :
  1. Relief of diabetic neuropathy pain [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Average daily pain score [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01521598

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United States, Alabama
Neurology Clinic, P.C.
Northport, Alabama, United States, 35476
United States, Arkansas
Principals Research Group
Hot Springs, Arkansas, United States, 71901
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
United States, California
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States, 90806
Neurological Research Institute
Santa Monica, California, United States, 90404
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 33471
Comprehensive Clinical Development
St. Petersburg, Florida, United States, 33716
Clinical Research of West Florida, Inc.
Tampa, Florida, United States, 33603
United States, Kansas
International Clinical Research Institute
Leawood, Kansas, United States, 66211
United States, Michigan
Michigan Head Pain & Neurological Institute.
Ann Arbor, Michigan, United States, 48104
United States, Nebraska
Creighton Diabetes Center
Omaha, Nebraska, United States, 68131
United States, Oregon
Sunstone Medical Research, LLC
Medford, Oregon, United States, 97504
United States, Texas
Nerve and Muscle Center of Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
SK Life Science, Inc.
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Study Director: Marc Kamin, M.D. SKLSI (Sponsor)

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Responsible Party: SK Life Science, Inc. Identifier: NCT01521598    
Other Study ID Numbers: SKL11197C006
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: May 2015
Keywords provided by SK Life Science, Inc.:
Diabetic Peripheral Neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases