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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Painful Diabetic Neuropathy
• Intervention / Treatment: Drug: SKL11197; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relief of diabetic neuropathy pain	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Average daily pain score	24 hours

Collaborators and Investigators

• Sponsor: SK Life Science, Inc.
• Investigators: Study Director: Marc Kamin, M.D., SKLSI (Sponsor)

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Estimate): June 11, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Diabetic Peripheral Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: SKL11197C006