Phase III Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy

Bukwang Pharmaceutical1 site in 1 country164 target enrollmentAugust 2010

InterventionsBK-C-0701

Overview

The purpose of this study is to determine the:

Primary end point

Secondary end point

total symptom score shall be calculated from the data of burning, numbness, stabbing pain, paraesthesiae.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

April 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Bukwang Pharmaceutical

•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).

•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).