A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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|
- Relief of diabetic neuropathy pain [ Time Frame: 24 hours ]
- Average daily pain score [ Time Frame: 24 hours ]
|Study Start Date:||January 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.
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.
This is the placebo. Patients will be randomized the placebo.
This study is a double-blind, placebo controlled study with three phases;
- a pre-study medication washout/screening phase upto 3 weeks
- a 3-week, open label phase
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521598
|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|
|Study Director:||Marc Kamin, M.D.||SKLSI (Sponsor)|