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

Painful Diabetic Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521598
• Other study ID #: SKL11197C006
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2012
• Last updated: May 18, 2015
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2015
• Source: SK Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Painful Diabetic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• SKL11197
SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.
• Placebo
This is the placebo. Patients will be randomized the placebo.

Locations

Country	Name	City	State
United States	Michigan Head Pain & Neurological Institute.	Ann Arbor	Michigan
United States	Principals Research Group	Hot Springs	Arkansas
United States	Nerve and Muscle Center of Texas	Houston	Texas
United States	International Clinical Research Institute	Leawood	Kansas
United States	Clinical Trials, Inc.	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, Inc.	Long Beach	California
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Neurology Clinic, P.C.	Northport	Alabama
United States	Renstar Medical Research	Ocala	Florida
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Neurological Research Institute	Santa Monica	California
United States	Comprehensive Clinical Development	St. Petersburg	Florida
United States	Clinical Research of West Florida, Inc.	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of diabetic neuropathy pain		24 hours	No
Secondary	Average daily pain score		24 hours	No