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

Diabetics Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01224353
• Other study ID #: NM2010001
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: October 17, 2010
• Last updated: October 19, 2010
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2010
• Source: NovaMed Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetics
• Polyneuropathies

Intervention

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

Locations

Country	Name	City	State
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	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Wuxi No.2 People's Hospital	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
NovaMed Pharmaceuticals Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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).	6 weeks	No
Secondary	To evaluate each sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP	Changes in the individual symptom scores of the TSS (Stabbing pain, burning, paraesthesia, numbness)	6 weeks	No
Secondary	To evaluate onset time of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP		6 weeks	No
Secondary	To evaluate response rate of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP		6 weeks	No
Secondary	To evaluate the tolerability and safety of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP	Number of adverse events and standard laboratory tests will be the Measures of Safety and Tolerability	6 weeks	Yes