Status:
UNKNOWN
Efficacy and Safety Study of Thioctacid Oral Tablets 600mg to Treat Chinese Diabetic Patients With Distal Symmetric Polyneuropathy
Lead Sponsor:
NovaMed Pharmaceuticals Inc.
Conditions:
Diabetics
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy on overall neuropathic sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic pati...
Eligibility Criteria
Inclusion
- Subjects must fulfil all of the following criteria to be appropriate to enter into Registry (Visit 2)
- Provision of informed consent
- Females and males aged from 18 to 75 (inclusive), who were definitely diagnosed with diabetes
- HbA1C\< 10％
- 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
- Total Symptom Score (TSS) \> 6.5 points
- At least one of the four symptoms of the TSS has occurred continuously over the last 3 months before screening
- 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：
- TSS \> 5 points
- TSS range (maximum TSS - minimum TSS during Run-in Period) \< 3 points during the Run-in Period
- Compliance in Run-in Period \> 85%
Exclusion
- Neurologic disease other than diabetic neuropathy that may produce weakness, sensory loss, or autonomic symptoms or test abnormality
- Peripheral vascular disease severe enough to cause intermittent claudication or ischemic ulcers
- Patients who have been hospitalized due to glucopenia or ketoacidosis in the last 3 month
- Present ulcers on lower limbs of any cause
- Antioxidant therapy within the last 1 month before screening (Vitamin E\> 400IU, Vitamin C\> 200mg once daily for continuous 2 weeks)
- Any ALA therapy within the last1 month before screening
- Opioid analgesic therapy within the last 1 month before screening
- History of mental, psychological or behavioral conditions rendering the patient unable to follow the protocol
- History of malignant tumors in the past 5 years except for basal cell carcinoma
- 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,
- ALT or AST \> 2.5 ´ upper limit of reference range
- Cr \> 1.8mg/dL ( \> 159µmol/L) for males or \> 1.6mg/dL ( \> 141µmol/L) for females
- History of hypersensitive to the active ingredients or excipients of ALA
- Participation in a clinical study or treatment with a non-approved experimental medication in the last 1 month
- Pregnant or breast-feeding women, or women of childbearing age without appropriate contraception measures
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01224353
Start Date
November 1 2010
End Date
July 1 2011
Last Update
October 21 2010
Active Locations (5)
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1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210029
2
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
3
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
4
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006