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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT01521598
First received: January 26, 2012
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Painful Diabetic Neuropathy
Drug: SKL11197
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • Relief of diabetic neuropathy pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average daily pain score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521598

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
Investigators
Study Director: Marc Kamin, M.D. SKLSI (Sponsor)
  More Information

No publications provided

Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT01521598     History of Changes
Other Study ID Numbers: SKL11197C006
Study First Received: January 26, 2012
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SK Life Science:
Diabetic Peripheral Neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on November 25, 2014