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

NCT01261143 | Completed Phase 3

• 1 other identifier: BK-C-0701-301
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the: Primary end point

• change of Total symptom score Secondary end point
• neurological test

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

• TSS

  8 weeks

Study Arms (2)

BK-C-0701, diabetic neuropathy

EXPERIMENTAL

Drug: BK-C-0701

alpha lipoic acid, diabetic neuropathy, capsule

ACTIVE COMPARATOR

Drug: BK-C-0701

Interventions

BK-C-0701 DRUG

tablet, 8 weeks

BK-C-0701, diabetic neuropathy; alpha lipoic acid, diabetic neuropathy, capsule

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Kyung soo Ko

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 16, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Last Updated: April 25, 2012

Record last verified: 2011-10

Locations

KR (1)