Clinical trial NCT01521598: A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Diabetic Neuropathy
Keywords: Diabetic Peripheral Neuropathy
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Relief of diabetic neuropathy pain
timeFrame: 24 hours
Secondary outcomes:
measure: Average daily pain score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Northport
country: United States
facility: Neurology Clinic, P.C.
state: Alabama
city: Hot Springs
country: United States
facility: Principals Research Group
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: St. Petersburg
country: United States
facility: Comprehensive Clinical Development
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Leawood
country: United States
facility: International Clinical Research Institute
state: Kansas
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute.
state: Michigan
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Houston
country: United States
facility: Nerve and Muscle Center of Texas
state: Texas
Study officials:
affiliation: SKLSI (Sponsor)
name: Marc Kamin, M.D.
role: STUDY_DIRECTOR
References: