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

NCT01224353 | Unknown Phase 2 DMC

• 1 other identifier: NM2010001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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).

Conditions

Diabetics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Thioctacid Oral Placebo Tablet

PLACEBO COMPARATOR

Other: Placebo

Thioctacid Oral Tablet

ACTIVE COMPARATOR

Drug: lipoic acid

Interventions

lipoic acid DRUG

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

Thioctacid Oral Tablet

Placebo OTHER

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

Thioctacid Oral Placebo Tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaMed Pharmaceuticals Inc.: lead

Study Sites (5)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, 214002, China

Location

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Qi Wan

  Jiangsu Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 17, 2010
• First Posted: October 20, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 21, 2010

Record last verified: 2010-10

Locations

CN (5)