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

• ClinicalTrials.gov Identifier: NCT01521598
• Recruitment Status: Completed
• First Posted: January 30, 2012
• Last Update Posted: June 11, 2015
• Sponsor: SK Life Science, Inc.
• Information provided by (Responsible Party): SK Life Science, Inc.

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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.

Investigators

• Study Director: Marc Kamin, M.D.; SKLSI (Sponsor)

More Information

• Responsible Party: SK Life Science, Inc.
• ClinicalTrials.gov Identifier: NCT01521598 History of Changes
• Other Study ID Numbers: SKL11197C006
• First Posted: January 30, 2012
• Last Update Posted: June 11, 2015
• Last Verified: May 2015

Keywords provided by SK Life Science, Inc.:

Diabetic Peripheral Neuropathy

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Diabetic Neuropathies; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases