Clinical trial NCT03914404: Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy
Official title: A 12-week, Multi-center, Randomized, Double-blind, Double Dummy, Parallel Clinical Trial to Compare the Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Neuropathy
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was a 12-week, multi-center, randomized, double-blind, double dummy, parallel clinical trial to compare the efficacy of γ-linolenic acid and Thioctic acid in patients with diabetic neuropathy.

Detailed description: This study evaluated non-inferiority about the efficacy and safety of γ-linolenic acid (Evoprim soft capsule) through patients with diabetic neuropathy were compared γ-linolenic acid (Evoprim soft capsule) and Thioctic acid(LipoA HR Tab. 600mg) using double-blind, double dummy clinical trials. First outcome measures are Visual Analog Scale(VAS) and Total Symptom Score(TSS), secondary outcome measures are Michigan Neuropathy Screening Instrument(MNSI), Current perception Threshold(CPT), Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN) and EuroQol-5 Dimensions(EQ 5D).

Eligibility criteria: Inclusion Criteria:

* Patients who were between 20 years and 75 years at screening
* Patients who were diagnosed with type 2 diabetes and whose HbA1c levels were less than 11% at screening
* Patients with a score of 4 or more on the Visual Analogue Score(VAS)
* One or more of the following items

  * If the physical examination score of the Michigan Neuropathy Screening Instrument Score (MNSI) is more than 2 points at the initial screening
  * type 2 diabetic patient who complained one or more of pain, burning sensation, numbness, and sensory loss and measured the current perception threshold (CPT) of the peroneal nerve at three frequencies (2000Hz, 250Hz, 5Hz) Anyone whose diabetes mellitus has been diagnosed as diabetic neuropathy
* Patients who decided to voluntarily participate in clinical trials and agreed in writing

Exclusion Criteria:

* Peripheral neuropathy caused by other causes other than diabetes
* Those are suffering from other painful conditions that are so severe that diabetic neuropathy can not be assessed
* If you have a progressive or degenerative neurological disorder
* Patients with a systolic blood pressure(SBP)≥ 160 mmHg or ≤ 100 mmHg or a diastolic blood pressure(DBP) ≥ 95 mmHg or ≤ 60 mmHg
* Patients who were positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) test
* patients with liver dysfunction (ALT / AST\> 3 times the upper limit of normal)
* Patients with renal dysfunction (Serum creatine\> 2.0 mg / dl)
* Patients with thyroid dysfunction (Thyroid and anti-thyroid medications may be included in this study if they are maintained in normal state.)
* Patients with amputation (including toes) or infections of the lower extremities
* The following diseases are clinically significant patients

  * Unstable coronary artery disease or peripheral vascular disease
  * Liver, kidney, lung, hematologic disease
  * Cancer (within 5 years if possible)
* Patients who have suicide attempts or suicidal tendencies and who have a psychiatric history within 6 months before starting the trial
* Patients with substance abuse or chronic alcohol abuse within 2 years prior to taking the test
* Patients who received intravenous steroid injection or topical anesthetic injection within 2 months before participating in the study
* Patients who participated in other studies within 4 weeks before participating in the trial, or who are currently taking medication for other research
* Screening After randomization for 2 weeks (pause period) before screening, antipsychotics, antipsychotics, sleep depressants, antidepressants, antiepileptics, muscle relaxants, analgesics (narcotic analgesics, NSAIDs, tramadol etc.) Patients who received capsaicin or who received percutaneous electrical nerve stimulation therapy (TENS) or acupuncture
* Patients with a history of hypersensitivity or clinically significant hypersensitivity reactions to this drug substance and soybean oil, soy or peanut
* Patients with clinically significant skin disease or severe skin irritability
* Pregnant or lactating women
* patients suffering from schizophrenia or those who are treated with chloropromazine, mesoridazine, thioridazine, fluphenazine, perphenazine, trifluoperazine, haloperidol (haloperidol), loxapine (loxapine) and other drugs known to cause epileptic seizures
* In addition to the above items, patients who are deemed inappropriate by clinical trial researchers

Primary outcomes:
measure: Changes of Visual Analog Scale(VAS)
timeFrame: 12 weeks
measure: Changes of Total Symptom Score(TSS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of Michigan Neuropathy Screening Instrument(MNSIQ)
timeFrame: 12 weeks
measure: Changes of Michigan Neuropathy Screening Instrument(MNSIE)
timeFrame: 12 weeks
measure: Changes of Current perception Threshold(CPT)
timeFrame: 12 weeks
measure: Changes of Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN)
timeFrame: 12 weeks
measure: Changes of EuroQol-5 Dimensions(EQ 5D)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong hospital
state: Gyeonggi
city: Jeonju
country: Korea, Republic of
facility: Obesity Research Center of Chonbuk National University
state: Jeollabuk-do
city: Gyeongju
country: Korea, Republic of
facility: Dongguk university gyeongju hospital
state: North Gyeongsang-do
city: Cheonan
country: Korea, Republic of
facility: Soon chun hyang university hospital cheonan
state: South Chungcheong Province
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Inje university sanggye paik hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei univesity severance hospital
city: Seoul
country: Korea, Republic of
facility: The catholic university of korea seoul st. mary's hospital
city: Seoul
country: Korea, Republic of
facility: The catholic university of korea Yeouido st. mary's hospital
Study officials:
affiliation: The Catholic University of Korea
name: Bong-Yeon Cha, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sejong General Hospital
name: Jong hwa Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University Gil Medical Center
name: Lee-byeong Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The catholic university of korea Yeouido st. mary's hospital
name: Hyuk Sang Kwon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: In Joo Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Catholic University Medical Center
name: Ji hyun Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: DongGuk University
name: sung soo Moon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soon Chun Hyang University
name: Sung wan Chun, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yonsei univesity severance hospital
name: Byung-Wan Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jong chul Won, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Tae-Sun Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: