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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by NovaMed Pharmaceuticals Inc..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224353
First Posted: October 20, 2010
Last Update Posted: October 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NovaMed Pharmaceuticals Inc.
  Purpose
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).

Condition Intervention Phase
Diabetics Drug: lipoic acid Other: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NovaMed Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To evaluate each sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP [ Time Frame: 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 [ Time Frame: 6 weeks ]
  • To evaluate response rate of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP [ Time Frame: 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 [ Time Frame: 6 weeks ]
    Number of adverse events and standard laboratory tests will be the Measures of Safety and Tolerability


Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Thioctacid Oral Placebo Tablet Other: Placebo
Tablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks
Active Comparator: Thioctacid Oral Tablet Drug: lipoic acid
Tablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224353


Locations
China, Jiangsu
Jiangsu Provincial People's Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210029
Contact: Qi Wan    86 13770316989    qi_wan@126.com   
Sub-Investigator: Jie Gong         
Sub-Investigator: Wei Wang         
Principal Investigator: Qi Wan         
Sub-Investigator: Ping Gu         
Affiliated Hospital of Nantong University Not yet recruiting
Nantong, Jiangsu, China, 226001
Contact: Kaifu Ke    0513-85052569    kekaifu_nt@126.com   
Sub-Investigator: Maohong Cao         
Principal Investigator: Kaifu Ke         
Sub-Investigator: Aihong Li         
The Second Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, Jiangsu, China, 215004
Contact: Heqing Zhao    86 13004571960    zhao_heqing@163.com   
Principal Investigator: Heqing Zhao         
Sub-Investigator: Xia Zhang         
Sub-Investigator: Weidong Hu         
The First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, Jiangsu, China, 215006
Contact: Wanli Dong    86 512 65223637 ext 8317    dwlsz@163.com   
Principal Investigator: Wanli Dong         
Sub-Investigator: Shouru Xue         
Sub-Investigator: Xiaowei Hu         
Sub-Investigator: Hongxia Wang         
Wuxi No.2 People's Hospital Not yet recruiting
Wuxi, Jiangsu, China, 214002
Contact: Yuenan Kong    86 051267727501 ext 3503    kkyynn2008@yahoo.cn   
Principal Investigator: Yuenan Kong         
Sub-Investigator: Wenzhuo Dai         
Sub-Investigator: Tao Ma         
Sponsors and Collaborators
NovaMed Pharmaceuticals Inc.
Investigators
Principal Investigator: Qi Wan Jiangsu Provincial People's Hospital
  More Information

Responsible Party: Wan Qi/Director, Neuropathic Department, Jiangsu Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT01224353     History of Changes
Other Study ID Numbers: NM2010001
First Submitted: October 17, 2010
First Posted: October 20, 2010
Last Update Posted: October 21, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances