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Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy (OPTIMUM)

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pregabalin 150mg + Alpha-lipoic acid 480mg
Pregabalin 150mg
Alpha-Lipoic Acid 480mg
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inje University Sanggye Paik HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Pregabalin and alpha-lipoic acid combination therapy

Pregabalin monotherapy

Alpha-lipoic acid monotherapy

Arm Description

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 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.

Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks.

Outcomes

Primary Outcome Measures

visual analogue scale (VAS)

Secondary Outcome Measures

visual analogue scale (VAS)
visual analogue scale (VAS) reduction rate of more than 30%
visual analogue scale (VAS) reduction rate of more than 50%
brief pain inventory Korean version, BPI-K
total symptom score, TSS
pain detect questionnaire, PD-Q
3 level version of Euro-Qol-5 dimensions, EQ-5D-3L

Full Information

First Posted
April 13, 2021
Last Updated
May 26, 2021
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04846673
Brief Title
Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy
Acronym
OPTIMUM
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin and alpha-lipoic acid combination therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Pregabalin monotherapy
Arm Type
Experimental
Arm Description
Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.
Arm Title
Alpha-lipoic acid monotherapy
Arm Type
Active Comparator
Arm Description
Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg + Alpha-lipoic acid 480mg
Intervention Description
Pregabalin qd + alpha-lipoic acid qd
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Intervention Description
pregabalin qd
Intervention Type
Drug
Intervention Name(s)
Alpha-Lipoic Acid 480mg
Intervention Description
alpha-lipoic acid qd
Primary Outcome Measure Information:
Title
visual analogue scale (VAS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
visual analogue scale (VAS)
Time Frame
6 weeks
Title
visual analogue scale (VAS) reduction rate of more than 30%
Time Frame
6 weeks, 12 weeks
Title
visual analogue scale (VAS) reduction rate of more than 50%
Time Frame
6 weeks, 12 weeks
Title
brief pain inventory Korean version, BPI-K
Time Frame
6 weeks, 12 weeks
Title
total symptom score, TSS
Time Frame
6 weeks, 12 weeks
Title
pain detect questionnaire, PD-Q
Time Frame
6 weeks, 12 weeks
Title
3 level version of Euro-Qol-5 dimensions, EQ-5D-3L
Time Frame
6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JC Won
Phone
82-2-950-8860
Email
drwonjc@gmail.com
Facility Information:
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JC Won

12. IPD Sharing Statement

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Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy

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