Trial | NCT01224353  Report issue

Title

Efficacy and Safety Study of Thioctacid Oral Tablets 600mg to Treat Chinese Diabetic Patients With Distal Symmetric Polyneuropathy
Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Thioctacid Oral Tablet 600mg Once Daily in Chinese Diabetic Patients With Distal Symmetric Polyneuropathy

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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 patients with distal symmetric polyneuropathy (DSP).
Study Started
Nov 30
2010
Primary Completion
May 31
2011
Anticipated
Study Completion
Jul 31
2011
Anticipated
Last Update
Oct 21
2010
Estimate

Drug lipoic acid

Tablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks

Other Placebo

Tablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks

Thioctacid Oral Placebo Tablet Placebo Comparator

Thioctacid Oral Tablet Active Comparator

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted