Efficacy and Safety Study of Thioctacid Oral Tablets 600mg to Treat Chinese Diabetic Patients With Distal Symmetric Polyneuropathy
NCT ID: NCT01224353
Last Updated: 2010-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2010-11-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Thioctacid Oral Placebo Tablet
Placebo
Tablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks
Thioctacid Oral Tablet
lipoic acid
Tablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks
Interventions
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lipoic acid
Tablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks
Placebo
Tablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks
Eligibility Criteria
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Inclusion Criteria
1. Provision of informed consent
2. Females and males aged from 18 to 75 (inclusive), who were definitely diagnosed with diabetes
3. HbA1C\< 10％
4. Moderate neuropathy according to Neuropathy Disability Score (NDS) \>= 4 points. Difference in score between left and right foot is not to be higher than 2 points
5. Total Symptom Score (TSS) \> 6.5 points
6. At least one of the four symptoms of the TSS has occurred continuously over the last 3 months before screening
7. Other concomitant treatments (the drugs and their dosage) have been stable over 1 month before screening Subjects must fulfil all of the following criteria before randomization：
8. TSS \> 5 points
9. TSS range (maximum TSS - minimum TSS during Run-in Period) \< 3 points during the Run-in Period
10. Compliance in Run-in Period \> 85%
Exclusion Criteria
2. Peripheral vascular disease severe enough to cause intermittent claudication or ischemic ulcers
3. Patients who have been hospitalized due to glucopenia or ketoacidosis in the last 3 month
4. Present ulcers on lower limbs of any cause
5. Antioxidant therapy within the last 1 month before screening (Vitamin E\> 400IU, Vitamin C\> 200mg once daily for continuous 2 weeks)
6. Any ALA therapy within the last1 month before screening
7. Opioid analgesic therapy within the last 1 month before screening
8. History of mental, psychological or behavioral conditions rendering the patient unable to follow the protocol
9. History of malignant tumors in the past 5 years except for basal cell carcinoma
10. Any severe systematic diseases, at the investigator's discretion, which will make it undesirable for the patient to participate in the trial or which could jeopardize compliance with the trial protocol,
11. ALT or AST \> 2.5 ´ upper limit of reference range
12. Cr \> 1.8mg/dL ( \> 159µmol/L) for males or \> 1.6mg/dL ( \> 141µmol/L) for females
13. History of hypersensitive to the active ingredients or excipients of ALA
14. Participation in a clinical study or treatment with a non-approved experimental medication in the last 1 month
15. Pregnant or breast-feeding women, or women of childbearing age without appropriate contraception measures
18 Years
75 Years
ALL
No
Sponsors
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NovaMed Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Neuropathic Department, Jiangsu Provincial People's Hospital
Principal Investigators
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Qi Wan
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial People's Hospital
Locations
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Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
Countries
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Facility Contacts
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Other Identifiers
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NM2010001
Identifier Type: -
Identifier Source: org_study_id