- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01261143
Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy
April 24, 2012 updated by: Bukwang Pharmaceutical
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
The purpose of this study is to determine the:
Primary end point
- change of Total symptom score
Secondary end point
- neurological test
Study Overview
Detailed Description
total symptom score shall be calculated from the data of burning, numbness, stabbing pain, paraesthesiae.
Study Type
Interventional
Enrollment (Anticipated)
164
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Kyung soo Ko
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BK-C-0701, diabetic neuropathy
|
tablet, 8 weeks
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Active Comparator: alpha lipoic acid, diabetic neuropathy, capsule
|
tablet, 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
TSS
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
December 10, 2010
First Submitted That Met QC Criteria
December 14, 2010
First Posted (Estimate)
December 16, 2010
Study Record Updates
Last Update Posted (Estimate)
April 25, 2012
Last Update Submitted That Met QC Criteria
April 24, 2012
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BK-C-0701-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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WinSanTor, IncCompletedPeripheral Neuropathy | Painful Diabetic Neuropathy | Diabetic Neuropathies, PainfulCanada
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Maastricht University Medical CenterCompletedPainful Diabetic Neuropathy | Diabetic Neuropathies, Painful | Neuralgia, DiabeticNetherlands
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Helixmith Co., Ltd.CompletedPainful Diabetic NeuropathiesUnited States, Korea, Republic of
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Corporacion Parc TauliCompletedDiabetic Neuropathy | Diabetic Nerve Problems | Diabetic Complications NeurologicalPakistan
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University Medical Centre LjubljanaUnknown
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Timothy J. Best Medicine Professional CorporationThe Physicians' Services Incorporated FoundationCompleted
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AbbVie (prior sponsor, Abbott)CompletedDiabetic Neuropathies | Diabetic Neuropathy, Painful | Diabetic Polyneuropathy | Diabetic Neuralgia | Neuralgia, DiabeticUnited States, Canada, France, Germany, Italy, Mexico, Puerto Rico
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