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
Recruitment status was Not yet recruiting
Sponsor:
NovaMed Pharmaceuticals Inc.
Information provided by:
NovaMed Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01224353
First received: October 17, 2010
Last updated: October 19, 2010
Last verified: October 2010
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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)
- 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
Contacts and Locations
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 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
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 Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Thioctic Acid Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 18, 2013