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

NCT01521598 | Completed Phase 2

• 1 other identifier: SKL11197C006
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 13

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.

Conditions

Painful Diabetic Neuropathy

Keywords

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Relief of diabetic neuropathy pain

  24 hours

Secondary Outcomes (1)

• Average daily pain score

  24 hours

Study Arms (2)

SKL11197

EXPERIMENTAL

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

Drug: SKL11197

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SKL11197 DRUG

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

SKL11197

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

Study Sites (13)

Neurology Clinic, P.C.

Northport, Alabama, 35476, United States

Location

Principals Research Group

Hot Springs, Arkansas, 71901, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

Collaborative Neuroscience Network, Inc.

Long Beach, California, 90806, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

Renstar Medical Research

Ocala, Florida, 33471, United States

Location

Comprehensive Clinical Development

St. Petersburg, Florida, 33716, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

International Clinical Research Institute

Leawood, Kansas, 66211, United States

Location

Michigan Head Pain & Neurological Institute.

Ann Arbor, Michigan, 48104, United States

Location

Creighton Diabetes Center

Omaha, Nebraska, 68131, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, 97504, United States

Location

Nerve and Muscle Center of Texas

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Kamin, M.D.

  SKLSI (Sponsor)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 11, 2015

Record last verified: 2015-05

Locations

US (13)