Status:
COMPLETED
Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT01261143
Start Date
August 1 2010
Last Update
April 25 2012
Active Locations (1)
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1
Kyung soo Ko
Seoul, South Korea