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Diabetic NeuropathyPhase 4NCT03914404

Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy

A Phase 4 study of Diabetic Neuropathy, run by Chonbuk National University Hospital at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Diabetic Neuropathy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
11 sitesSouth Korea
Study dates
26 Jan 2016to 25 Jul 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Sejong hospital

    Bucheon-si, Gyeonggi-do, 14754

  • Soon chun hyang university hospital cheonan

    Cheonan, South Chungcheong Province, 31151

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Dongguk university gyeongju hospital

    Gyeongju, North Gyeongsang-do, 38067

  • Gachon University Gil Medical Center

    Incheon, 2156

  • Obesity Research Center of Chonbuk National University

    Jeonju, Jeollabuk-do, 54907

  • Pusan National University Hospital

    Pusan, 49241

  • Inje university sanggye paik hospital

    Seoul, 01757

  • Yonsei univesity severance hospital

    Seoul, 03722

  • The catholic university of korea seoul st. mary's hospital

    Seoul, 06591

  • The catholic university of korea Yeouido st. mary's hospital

    Seoul, 07345

Other trials in South Korea

About this study

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

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.

Read the 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).

Being tested
γ-linoleic acid and placebo(Thioctic Acid), Thioctic Acid and placebo(γ-linoleic acid)
Medical subject headings
Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • γ-linoleic acid and placebo(Thioctic Acid)Drug

    • γ-linoleic acid (Evoprim soft capsule) twice a day and 4 capsules at a time.
    • Thioctic Acid(LipoA HR Tab. 600mg) placebo once a day and 1 tablet at a time.

  • Thioctic Acid and placebo(γ-linoleic acid)Drug

    • Thioctic Acid(LipoA HR Tab. 600mg) once a day and 1 tablet at a time.
    • γ-linoleic acid (Evoprim soft capsule) placebo twice a day and 4 capsules at a time.
Study groups in NCT03914404
Study groupRoleWhat they receive
Test groupExperimental* γ-linoleic acid (Evoprim soft capsule) twice a day and 4 capsules at a time. * Thioctic Acid(LipoA HR Tab. 600mg) placebo once a day and 1 tablet at a time.
Receives: Drug: γ-linoleic acid and placebo(Thioctic Acid)
Control GroupExperimental* Thioctic Acid(LipoA HR Tab. 600mg) once a day and 1 tablet at a time. * γ-linoleic acid (Evoprim soft capsule) placebo twice a day and 4 capsules at a time.
Receives: Drug: Thioctic Acid and placebo(γ-linoleic acid)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of Visual Analog Scale(VAS)

    The Visual Analog Scale(VAS) score is 0 point for no symptom, 10 points for the most severe symptom, and the patient is asked to mark the degree of subjective pain symptoms as an integer.

    Measured: 12 weeks

  2. Changes of Total Symptom Score(TSS)

    Total Symptom Score(TSS) classifies diabetic neuropathy symptoms into four categories (pain, burning pain, paresthesia, numbness). The frequency (Occasional, Frequent, Continuous) and symptom intensity (Absent, Slight, Moderate, Severe) are calculated through each question and the score is obtained according to the visual analog scale. It is calculated from 0 point up to 14.64 points.

    Measured: 12 weeks

Secondary outcomes (5)

  1. Changes of Michigan Neuropathy Screening Instrument(MNSIQ)

    A 15-item questionnaire (MNSIQ) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers.

    MNSIQ was designed to screen for diabetic neuropathy through questionnaires on 15 questions that are related to neuropathic symptoms (pain, temperature, and sensation). Two of 15 (number 4 and 10) are vascular symptoms and are excluded from the total score regardless of the results. If you answered 'No' to questions 7 and 13, you will get 1 point. In the end, scores ranging from 0 to 13 indicate that the higher the score, the more severe the neuropathic symptoms.

    Measured: 12 weeks

  2. Changes of Michigan Neuropathy Screening Instrument(MNSIE)

    A foot test (MNSIE) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers.

    MNSIE evaluates foot shape, foot ulceration, ankle reflex, sense of vibration of big toe, monofilament right and left. The score ranges from point 0 to 10, and when the score is above 2, it is diagnosed as neuropathy.

    Measured: 12 weeks

  3. Changes of Current perception Threshold(CPT)

    Sensory nerve conduction threshold (SNCT) is a unique method for evaluating all three sensory neurons (small unmyelinated fibers, small myelinated fibers, and large myelinated fibers) that make up more than 90% of sensory nerves. It seems to be possible to objectively evaluate sensory nerve of small fiber which recovered early in diabetic neuropathy(Using neurometer).

    Measured: 12 weeks

  4. Changes of Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN)

    Modified Brief Pain Inventory-diabetic polyneuropathy(Modified BPI-DPN) displays the pain area on the human figure, the number of pain sites, treatment of pain, and pain medication.

    Pain severity refers to the pain sensation- identification aspect (pain threshold). The worst pain, the least pain, the pain average, and the pain now for the last 24 hours are displayed on the 10-point scale (0 points: none, ~ 10 Point: too big to imagine). Pain interference is the emotional-synchronous aspect of pain (pain tolerance). It classifies general activity, mood, walking, working, relationship, sleep and enjoyment of life, and use the 10-point scale (0 points: none to 10 points: completely disturbed).

    Measured: 12 weeks

  5. Changes of EuroQol-5 Dimensions(EQ 5D)

    EQ-5D index = 1 - (0.050 + 0.096 M2 + 0.418 x M3 + 0.046 x SC2 + 0.13 x SC3 + 0.051 x UA2 + 0.028 x UA3 + 0.037 x PD2 + 0.151 x PD3 + 0.043 x AD2 + 0.158 x AD3 + 0.050 × N3) - 1 if the variable is applicable, 0 if not (M: mobility, SC: self-care, UA: usual activity,, PD: pain / discomfort, AD: anxiety / depression)

    • Variable definition
    • M2: 1 if mobility is 'level 2', 0 if not
    • M3: 1 if mobility is 'level 3', 0 if not
    • SC2: 1 if self-care is 'level 2', 0 if not
    • SC3: 1 if self-care is 'level 3', 0 if not
    • UA2: 1 if usual activity is 'level 2', 0 if not
    • UA3: 1 if usual activity is 'level 3', 0 if not
    • PD2: 1 if pain / discomfort is 'level 2', 0 if not
    • PD3: 1 if pain / discomfort is 'level 3', 0 if not
    • AD2: 1 if anxiety / depression is 'level 2', 0 if not
    • AD3: 1 if anxiety / depression is 'level 3', 0 if not
    • N3: 1 if there is at least one level 3, others are 0

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start26 Jan 2016
  3. Primary completion30 Mar 2016
  4. Study completion25 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03914404
Sponsor's protocol ID
DLB-DN-EVOP
Status last verified
Apr 2019
First submitted
10 Apr 2019
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Diabetic Neuropathy, run by Chonbuk National University Hospital at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of Visual Analog Scale(VAS) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03914404.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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