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

NCT ID: NCT01521598

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-06-30

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;

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.

Conditions

Painful Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SKL11197

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

Group Type: EXPERIMENTAL

SKL11197

Intervention Type: DRUG

SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

This is the placebo. Patients will be randomized the placebo.

Interventions

SKL11197

SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.

Intervention Type: DRUG

Placebo

This is the placebo. Patients will be randomized the placebo.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Life Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Kamin, M.D.

Role: STUDY_DIRECTOR

SKLSI (Sponsor)

Locations

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

Countries

United States

Other Identifiers

SKL11197C006

Identifier Type: -

Identifier Source: org_study_id