Status:
COMPLETED
Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy
Lead Sponsor:
Yuhan Corporation
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
19-75 years
Phase:
PHASE4
Brief Summary
This study is a randomized, parallel, open-label, multicenter, phase IV clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy ...
Eligibility Criteria
Inclusion
- aged 19 to 75
- type 2 diabetes mellitus with HbA1c (Hemoglobin A1c) ≤ 10 %
- peripheral (eg. hands, feet) neuropathic pain (eg. abnormal sensations, numbness, pain, etc.) within 3 months (12 weeks)
- diagnosed with diabetic peripheral neuropathy (DPN)
- VAS pain score ≥ 40 mm
- written informed consent
Exclusion
- brittle diabetes mellitus
- ALT (Alanine Transaminase), AST (Aspartate Transaminase), CPK (Creatine Phosphokinase) level ≥ 3 times the upper limit of normal (UNL) or active liver disease
- severe renal impairment (eGFR (estimated glomerular filtration rate) \< 60 mL/min/ 1.73m2)
- treated with antiepileptic drugs within 1 week at randomization
- other nervous system or neuropathic disorders that may affect pain evaluation
- oral drug administration is not possible, or hypersensitive or allergic to pregabalin, r-thioctic acid tromethamine, thioctic acid, and other excipients
- pregnant, lactating, or childbearing potential
- alcoholics, drug abusers, and patients who are difficult to participate in clinical trials due to psychological and emotional problems
- have participated in other clinical trials within 30 days at screening
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04846673
Start Date
May 14 2021
End Date
November 30 2022
Last Update
April 3 2025
Active Locations (14)
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1
Pusan National University Hospital
Busan, South Korea
2
Chosun University Hospital, School of Medicine, Chosun University
Gwangju, South Korea
3
Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Gyeonggi-do, South Korea
4
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea