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

Completed · Phase 2 · Has a placebo group

Conditions studied: Painful Diabetic Neuropathy

In brief

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.

Key facts

Study ID

NCT01521598

Run by

SK Life Science, Inc.

People needed

128

Starts

2012-01-01

Expected to finish

2013-06-01

Last updated by the study team

2015-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Neurology Clinic, P.C. — Northport, Alabama, United States
• Principals Research Group — Hot Springs, Arkansas, United States
• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• Collaborative Neuroscience Network, Inc. — Long Beach, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Renstar Medical Research — Ocala, Florida, United States
• Comprehensive Clinical Development — St. Petersburg, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• International Clinical Research Institute — Leawood, Kansas, United States
• Michigan Head Pain & Neurological Institute. — Ann Arbor, Michigan, United States
• Creighton Diabetes Center — Omaha, Nebraska, United States
• Sunstone Medical Research, LLC — Medford, Oregon, United States
• Nerve and Muscle Center of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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