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



Status:Completed
Conditions:Diabetic Neuropathy, Neurology
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:January 2012
End Date:June 2013
Contact:Marc Kamin, M.D.
Email:mkamin@sklsi.com
Phone:201 421 3830

Use our guide to learn which trials are right for you!

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy


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.


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.

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.
We found this trial at
11
sites
St. Petersburg, Florida 33716
?
mi
from
St. Petersburg, FL
Click here to add this to my saved trials
2147 Northeast Coachman Road
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
?
mi
from
Medford, OR
Click here to add this to my saved trials
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Leawood, KS
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
?
mi
from
Tulsa, OK
Click here to add this to my saved trials