DiabeticsPhase 2/3NCT01224353
Efficacy and Safety Study of Thioctacid Oral Tablets 600mg to Treat Chinese Diabetic Patients With Distal Symmetric Polyneuropathy
A Phase 2/3 study testing lipoic acid in people with Diabetics, run by NovaMed Pharmaceuticals Inc. at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetics
- What is being tested?
- lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
Qi Wan, 86 13770316989, qi_wan@126.com
Jie Gong
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Kaifu Ke, 0513-85052569, kekaifu_nt@126.com
Maohong Cao
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Heqing Zhao, 86 13004571960, zhao_heqing@163.com
Heqing Zhao
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Wanli Dong, 86 512 65223637 ext. 8317, dwlsz@163.com
Wanli Dong
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 214002
Yuenan Kong, 86 051267727501 ext. 3503, kkyynn2008@yahoo.cn
Yuenan Kong
About this study
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
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).
- Conditions
- Diabetics
- Being tested
- lipoic acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipoic acidDrug
Tablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks
PlaceboOther
Tablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Thioctacid Oral Placebo Tablet | Placebo comparator | Not described Receives: Other: Placebo |
| Thioctacid Oral Tablet | Active comparator | Not described Receives: Drug: lipoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (4)
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)
Measured: 6 weeks
To evaluate onset time of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
Measured: 6 weeks
To evaluate response rate of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP
Measured: 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
Number of adverse events and standard laboratory tests will be the Measures of Safety and Tolerability
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabeticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaMed Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Qi Wan, Principal investigator, Jiangsu Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224353
- Sponsor's protocol ID
- NM2010001
- Status last verified
- Oct 2010
- First submitted
- 17 Oct 2010
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01224353
- Acronym / sponsor ID
- NM2010001
- Conditions
- Diabetics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NovaMed Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thioctacid Oral Placebo Tablet | Placebo comparator | Other: Placebo |
| Thioctacid Oral Tablet | Active comparator | Drug: lipoic acid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must fulfil all of the following criteria to be appropriate to enter into Registry (Visit 2)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lipoic acidTablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks | Drug | Thioctacid Oral Tablet |
| PlaceboTablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks | Other | Thioctacid Oral Placebo Tablet |
Primary outcome
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).
4 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Wan principal investigator
Jiangsu Provincial People's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lipoic acid in people with Diabetics, run by NovaMed Pharmaceuticals Inc. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2010.