Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy
NCT ID: NCT04846673
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
151 participants
INTERVENTIONAL
2021-05-14
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
NCT01057693
Pregabalin Peripheral Neuropathic Pain Study
NCT00141219
Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
NCT01455415
A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
NCT00156078
A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)
NCT00643760
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pregabalin and alpha-lipoic acid combination therapy
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 150mg + Alpha-lipoic acid 480mg
Pregabalin qd + alpha-lipoic acid qd
Pregabalin monotherapy
Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.
Pregabalin 150mg
pregabalin qd
Alpha-lipoic acid monotherapy
Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks.
Alpha-Lipoic Acid 480mg
alpha-lipoic acid qd
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pregabalin 150mg + Alpha-lipoic acid 480mg
Pregabalin qd + alpha-lipoic acid qd
Pregabalin 150mg
pregabalin qd
Alpha-Lipoic Acid 480mg
alpha-lipoic acid qd
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
19 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yuhan Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jongchul Won
Role: PRINCIPAL_INVESTIGATOR
Inje University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pusan National University Hospital
Busan, , South Korea
Chosun University Hospital, School of Medicine, Chosun University
Gwangju, , South Korea
Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, , South Korea
Jeju National University College of Medicine
Jeju City, , South Korea
Jeonbuk National University Hospital
Jeollabuk-do, , South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul St.Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Yeouido St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Ulsan University Hospital, College of Medicine University of Ulsan
Ulsan, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YMC045
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.