Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- Registration Number
- NCT04846673
- Lead Sponsor
- Yuhan Corporation
- 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 in patients with diabetic peripheral neuropathy for 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pregabalin and alpha-lipoic acid combination therapy Pregabalin 150mg + Alpha-lipoic acid 480mg Alpha-lipoic acid 480 mg/tablet once daily before breakfast and Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks. Pregabalin monotherapy Pregabalin 150mg Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks. Alpha-lipoic acid monotherapy Alpha-Lipoic Acid 480mg Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks.
- Primary Outcome Measures
Name Time Method visual analogue scale (VAS) 12 weeks
- Secondary Outcome Measures
Name Time Method visual analogue scale (VAS) 6 weeks visual analogue scale (VAS) reduction rate of more than 30% 6 weeks, 12 weeks brief pain inventory Korean version, BPI-K 6 weeks, 12 weeks visual analogue scale (VAS) reduction rate of more than 50% 6 weeks, 12 weeks 3 level version of Euro-Qol-5 dimensions, EQ-5D-3L 6 weeks, 12 weeks pain detect questionnaire, PD-Q 6 weeks, 12 weeks total symptom score, TSS 6 weeks, 12 weeks
Trial Locations
- Locations (14)
Dongtan Sacred Heart Hospital, Hallym University College of Medicine
🇰🇷Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, Incheon ST. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Jeju National University College of Medicine
🇰🇷Jeju, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeollabuk-do, Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chosun University Hospital, School of Medicine, Chosun University
🇰🇷Gwangju, Korea, Republic of
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St.Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Yeouido St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital, College of Medicine University of Ulsan
🇰🇷Ulsan, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of