Status:
UNKNOWN
Efficacy and Safety of KW21052 Compared to Lyrica in the Diabetic Patients With Neuropathic Pain
Lead Sponsor:
KunWha Pharmaceutical Co., Ltd.
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep...
Detailed Description
Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.
Eligibility Criteria
Inclusion
- Type 1 and 2 diabetic patients
- Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy
- 40mm and more on VAS
- 4 and more on NRS
- Informed consented patients
Exclusion
- Participating in another clinical trial
- Pregnancy or lactating
- Sensitivity to pregabalin
- Significant underlying disease or disorders
- Prohibited concomitant medications
- Significant laboratory abnormalities
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT01863810
Start Date
August 1 2013
End Date
October 1 2014
Last Update
May 29 2013
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea