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

Diabetic Neuropathies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261143
• Other study ID #: BK-C-0701-301
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2010
• Last updated: April 24, 2012
• Start date: August 2010

Study information

• Verified date: October 2011
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the:

Primary end point

• change of Total symptom score

Secondary end point

• neurological test

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

Drug:
• BK-C-0701
tablet, 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Kyung soo Ko	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TSS		8 weeks	Yes