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 because the information has not been verified recently.
Verified October 2010 by NovaMed Pharmaceuticals Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
NovaMed Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01224353
First received: October 17, 2010
Last updated: October 19, 2010
Last verified: October 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 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         
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         
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

No publications provided

Responsible Party: Wan Qi/Director, Neuropathic Department, Jiangsu Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT01224353     History of Changes
Other Study ID Numbers: NM2010001
Study First Received: October 17, 2010
Last Updated: October 19, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Polyneuropathies
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014