A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 120
Summary
- Conditions
- Painful Diabetic Neuropathy
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 eligib...
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.
Tracking Information
- NCT #
- NCT01521598
- Collaborators
- Not Provided
- Investigators
- Study Director: Marc Kamin, M.D. SKLSI (Sponsor)
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