Status:
COMPLETED
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 sub...
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 A...
Eligibility Criteria
Inclusion
- 18 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01521598
Start Date
January 1 2012
End Date
June 1 2013
Last Update
June 11 2015
Active Locations (13)
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1
Neurology Clinic, P.C.
Northport, Alabama, United States, 35476
2
Principals Research Group
Hot Springs, Arkansas, United States, 71901
3
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
4
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States, 90806