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

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01261143
First received: December 10, 2010
Last updated: April 24, 2012
Last verified: October 2011
  Purpose

The purpose of this study is to determine the:

Primary end point

  • change of Total symptom score

Secondary end point

  • neurological test

Condition Intervention Phase
Diabetic Neuropathies
Drug: BK-C-0701
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • TSS [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 164
Study Start Date: August 2010
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BK-C-0701, diabetic neuropathy Drug: BK-C-0701
tablet, 8 weeks
Active Comparator: alpha lipoic acid, diabetic neuropathy, capsule Drug: BK-C-0701
tablet, 8 weeks

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261143

Locations
Korea, Republic of
Kyung soo Ko
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

No publications provided

Responsible Party: Hunjun Jang, bukwang
ClinicalTrials.gov Identifier: NCT01261143     History of Changes
Other Study ID Numbers: BK-C-0701-301
Study First Received: December 10, 2010
Last Updated: April 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Diabetic Neuropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Thioctic Acid
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014