Clinical trial NCT04846673: Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy
Official title: Efficacy and Safety of Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy: a Randomized, Parallel, Open-label, Multicenter, Phase IV Clinical Trial (OPTIMUM Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-15
Enrollment: 151
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: visual analogue scale (VAS)
timeFrame: 6 weeks
measure: visual analogue scale (VAS) reduction rate of more than 30%
timeFrame: 6 weeks, 12 weeks
measure: visual analogue scale (VAS) reduction rate of more than 50%
timeFrame: 6 weeks, 12 weeks
measure: brief pain inventory Korean version, BPI-K
timeFrame: 6 weeks, 12 weeks
measure: total symptom score, TSS
timeFrame: 6 weeks, 12 weeks
measure: pain detect questionnaire, PD-Q
timeFrame: 6 weeks, 12 weeks
measure: 3 level version of Euro-Qol-5 dimensions, EQ-5D-3L
timeFrame: 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital, School of Medicine, Chosun University
city: Gyeonggi-do
country: Korea, Republic of
facility: Dongtan Sacred Heart Hospital, Hallym University College of Medicine
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon ST. Mary's Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University College of Medicine
city: Jeollabuk-do
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital, The Catholic University of Korea
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital, College of Medicine University of Ulsan
Study officials:
affiliation: Inje University
name: Jongchul Won
role: PRINCIPAL_INVESTIGATOR
References: