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

Primary Purpose

Diabetics

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
lipoic acid
Placebo
Sponsored by
NovaMed Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jiangsu Provincial People's Hospital
  • Affiliated Hospital of Nantong University
  • The Second Affiliated Hospital of Soochow University
  • The First Affiliated Hospital of Soochow University
  • Wuxi No.2 People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Thioctacid Oral Placebo Tablet

Thioctacid Oral Tablet

Arm Description

Outcomes

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)
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
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
To evaluate response rate of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
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

Full Information

First Posted
October 17, 2010
Last Updated
October 19, 2010
Sponsor
NovaMed Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01224353
Brief Title
Efficacy and Safety Study of Thioctacid Oral Tablets 600mg to Treat Chinese Diabetic Patients With Distal Symmetric Polyneuropathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
NovaMed Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thioctacid Oral Placebo Tablet
Arm Type
Placebo Comparator
Arm Title
Thioctacid Oral Tablet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
lipoic acid
Intervention Description
Tablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Tablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
To evaluate each sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
Description
Changes in the individual symptom scores of the TSS (Stabbing pain, burning, paraesthesia, numbness)
Time Frame
6 weeks
Title
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
Title
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
Title
To evaluate the tolerability and safety of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
Description
Number of adverse events and standard laboratory tests will be the Measures of Safety and Tolerability
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 Compliance in Run-in Period > 85% 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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Wan
Organizational Affiliation
Jiangsu Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial People's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Wan
Phone
86 13770316989
Email
qi_wan@126.com
First Name & Middle Initial & Last Name & Degree
Jie Gong
First Name & Middle Initial & Last Name & Degree
Wei Wang
First Name & Middle Initial & Last Name & Degree
Qi Wan
First Name & Middle Initial & Last Name & Degree
Ping Gu
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaifu Ke
Phone
0513-85052569
Email
kekaifu_nt@126.com
First Name & Middle Initial & Last Name & Degree
Maohong Cao
First Name & Middle Initial & Last Name & Degree
Kaifu Ke
First Name & Middle Initial & Last Name & Degree
Aihong Li
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heqing Zhao
Phone
86 13004571960
Email
zhao_heqing@163.com
First Name & Middle Initial & Last Name & Degree
Heqing Zhao
First Name & Middle Initial & Last Name & Degree
Xia Zhang
First Name & Middle Initial & Last Name & Degree
Weidong Hu
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanli Dong
Phone
86 512 65223637
Ext
8317
Email
dwlsz@163.com
First Name & Middle Initial & Last Name & Degree
Wanli Dong
First Name & Middle Initial & Last Name & Degree
Shouru Xue
First Name & Middle Initial & Last Name & Degree
Xiaowei Hu
First Name & Middle Initial & Last Name & Degree
Hongxia Wang
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214002
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuenan Kong
Phone
86 051267727501
Ext
3503
Email
kkyynn2008@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Yuenan Kong
First Name & Middle Initial & Last Name & Degree
Wenzhuo Dai
First Name & Middle Initial & Last Name & Degree
Tao Ma

12. IPD Sharing Statement

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

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