A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
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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. |
ClinicalTrials.gov Identifier: NCT01521598 |
Recruitment Status :
Completed
First Posted : January 30, 2012
Last Update Posted : June 11, 2015
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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 |
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.
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 |

Arm | Intervention/treatment |
---|---|
Experimental: SKL11197
This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.
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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.
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Drug: Placebo
This is the placebo. Patients will be randomized the placebo. |
- Relief of diabetic neuropathy pain [ Time Frame: 24 hours ]
- Average daily pain score [ Time Frame: 24 hours ]

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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:
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01521598
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 |
Study Director: | Marc Kamin, M.D. | SKLSI (Sponsor) |
Responsible Party: | SK Life Science, Inc. |
ClinicalTrials.gov Identifier: | NCT01521598 History of Changes |
Other Study ID Numbers: |
SKL11197C006 |
First Posted: | January 30, 2012 Key Record Dates |
Last Update Posted: | June 11, 2015 |
Last Verified: | May 2015 |
Diabetic Peripheral Neuropathy |
Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |