Clinical trial NCT01224353: Efficacy and Safety Study of Thioctacid Oral Tablets 600mg to Treat Chinese Diabetic Patients With Distal Symmetric Polyneuropathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetics
Lead sponsor: NovaMed Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 patients with distal symmetric polyneuropathy (DSP).


Eligibility criteria: Inclusion Criteria:

* Subjects must fulfil all of the following criteria to be appropriate to enter into Registry (Visit 2)

  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:

1. Neurologic disease other than diabetic neuropathy that may produce weakness, sensory loss, or autonomic symptoms or test abnormality
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

Primary outcomes:
measure: 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)
timeFrame: 6 weeks
Secondary outcomes:
measure: To evaluate each sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
timeFrame: 6 weeks
measure: To evaluate onset time of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
timeFrame: 6 weeks
measure: To evaluate response rate of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
timeFrame: 6 weeks
measure: To evaluate the tolerability and safety of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial People's Hospital
name: Qi Wan
role: PRINCIPAL_INVESTIGATOR
References: