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

October 19, 2010 updated by: NovaMed Pharmaceuticals Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Provincial People's Hospital
      • Nantong, Jiangsu, China, 226001
        • Affiliated Hospital of Nantong University
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China, 214002
        • Wuxi No.2 People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
6 weeks
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
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
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NovaMed Pharmaceuticals Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qi Wan, Jiangsu Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NM2010001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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