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

NovaMed Pharmaceuticals Inc.5 sites in 1 country200 target enrollmentNovember 2010

ConditionsDiabetics

InterventionsPlacebo lipoic acid

Drugslipoic acid

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Diabetics
Sponsor: NovaMed Pharmaceuticals Inc.
Enrollment: 200
Locations: 5
Primary Endpoint: 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)
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

July 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NovaMed Pharmaceuticals Inc.

Eligibility 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

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,

Arms & Interventions

Thioctacid Oral Placebo Tablet

Intervention: Placebo

Thioctacid Oral Tablet

Intervention: lipoic acid

Outcomes

Primary Outcomes

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)

Time Frame: 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 Outcomes

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)
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)