NCT01521598

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	SKL11197	SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.
DRUG	Placebo	This is the placebo. Patients will be randomized the placebo.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-01-30
• Last updated: 2015-06-11

Locations

13 sites across 1 country: United States