Diabetic Neuropathies
Conditions
Brief summary
The purpose of this study is to determine the: Primary end point * change of Total symptom score Secondary end point * neurological test
Detailed description
total symptom score shall be calculated from the data of burning, numbness, stabbing pain, paraesthesiae.
Interventions
DRUGBK-C-0701
tablet, 8 weeks
Sponsors
Bukwang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year and is well-controlled. * Patient with symmetric sensory-motor Diabetic Neuropathy which is above stage 2 * Result of pin-prick test is 'absent' or 'reduced' * HbA1C \<10% * Total Symptom Score ≥ 4 points * At least 1 of the 4 symptoms of the TSS must have occurred continuously over the last 3 months. * Patient over 19 years of age * Female who is postmenopausal or is willing to use an effective method of contraception during the study (Effective method=IUD, spermicide with condom, abstinence) or is surgically sterile (underwent a total hysterectomy or bilateral tubal ligation).
Exclusion criteria
* Patient who has Proximal asymmetric neuropathy, cranial neuropathies, truncal radiculopathy, diabetic plexopathies, acute or active mononeuropathies (cranial neuropathies, post-herpes neuralgias) * Patient who has Neuropathy from alcohol, drug (cisplatin, taxol , etcs), malignant cancer or has a medical history of nerve system disease such as Parkinson's disease/ epilepsy/ Multiple sclerosis, etcs. * Patient who has nerve system disease which can cause sensory loss Myopathy of any cause. * Peripheral vascular disease severe enough to cause ischemic ulcers or limb ischemia. * Patients with diabetic proliferating retinopathy requiring immediately therapy and impending blindness. * Patients with any active neoplastic disease except benign tumor or nonrecurrent malignant tumor for 5 years. * Patients with clinically significant cardiac, pulmonary, gastrointestinal, haematological, or endocrine disease that may confound interpretation of the study results or prevent the patient from completing the study. * Patients with atrial fibrillation. * Patients who have had organ transplants of any kind. * Patients with significant hepatic or renal disease (AST, ALT or GGT \>2 times normal, serum creatinine \>1.8 mg/dL (\>159 mmol/l) for males or \>1.6 mg/dL (\>141 mmol/l) for females). * Patients with a recent history (within last 12 months) of drug or alcohol abuse. * Use of any investigational drug (participation in a clinical trial) within last 1 month. * History of severe or anaphylactic reaction to drugs, sulfur or biologic products. * Recent (within last 3 months) ketoacidosis or hypoglycaemia, necessitating hospital admission. * Existing foot ulcers. * Pregnant or lactating females * History of allergic reaction to the study medication or its excipients. * Psychiatric, psychological, or behavioural symptoms that would interfere with the patient's ability to participate in the trial. * Patient who is not suitable to trial by investigator judgment. * Patient who does not write informed consent prior to start of trial and cannot comply with the trial requirements. * Antioxidant therapy (vitamins E \> 400 IU, C \> 200 mg, and beta-Carotene \> 30 mg) or pentoxyphylline within last 1 month before start of trial. * Use of thioctic acid (\> 50 mg), evening primrose oil or any other gamma-linolenic acid containing substance within the last 3 months. * Use of analgesic within \>5times of a half-life before administration of investigational medication. * Use of anticonvulsants(include Pregabalin), antidepressants within 4 weeks before administration of investigational medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TSS | 8 weeks |
Countries
South Korea
Outcome results
None listed