Efficacy and Safety Study of Thioctacid Oral Tablets 600mg to Treat Chinese Diabetic Patients With Distal Symmetric Polyneuropathy

Phase 2

• Conditions: Diabetics
• Interventions: Other: Placebo; Drug: lipoic acid

• Registration Number: NCT01224353
• Lead Sponsor: NovaMed Pharmaceuticals Inc.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study First Submitted: 2010-10-17
• Study First Submitted QC: 2010-10-18
• Last Update Submitted: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Posted: 2010-10-21
• Study Start: 2010-11
• Primary Completion: 2011-05
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thioctacid Oral Placebo Tablet	Placebo	-
Thioctacid Oral Tablet	lipoic acid	-

Primary Outcome Measures

Name	Time	Method
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)	6 weeks	Changes from baseline in Total Symptom Score (TSS) from week 1 to week 6 will be computed and summarized in an Area Under the Curve (AUC).

Secondary Outcome Measures

Name	Time	Method
To evaluate each sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP	6 weeks	Changes in the individual symptom scores of the TSS (Stabbing pain, burning, paraesthesia, numbness)
To evaluate onset time of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP	6 weeks
To evaluate response rate of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP	6 weeks
To evaluate the tolerability and safety of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP	6 weeks	Number of adverse events and standard laboratory tests will be the Measures of Safety and Tolerability

Trial Locations

Locations (5)

The Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Wuxi No.2 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China