Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
239 participants
INTERVENTIONAL
2008-08-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALC
ALC
Acetylcarnitine
Administration of enteric-coated tablets with warm water at half an hour after meals, 1g (2 tablets) each time, 3 times a day, and the interval at or \>4 hours for 8 weeks
Placebo
Placebo
3 t.i.d, two plates per time
Interventions
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Acetylcarnitine
Administration of enteric-coated tablets with warm water at half an hour after meals, 1g (2 tablets) each time, 3 times a day, and the interval at or \>4 hours for 8 weeks
Placebo
3 t.i.d, two plates per time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or Female
* Age 18-75 years old
* Patients who have treated with Taxoids, Satraplatin and Vincristine; The peripheral sensory neuropathy grading after chemotherapy was \>/=grade 3 or grade 2 lasting for one month
* The course of neuropathy was \</=6 months
* No need to continue chemotherapy according to the condition nor refusing chemotherapy
* At least one of the neuroelectrophysiological examine results were abnormal
* Physical Condition Score (KPS) \>/=60
* Anticipated lifetime\>/=60.
Exclusion Criteria
* Diabetics
* Peripheral sensory neuropathy was induced by Vitamin deficiency, infections, trauma, toxicosis, compression, and ischemia
* Peripheral sensory neurologic dysfunction that induced by lesions of central nervous system; hereditary neuropathy
* Patients who have treated by other medicines for peripheral sensory neuropathy in 30 days
* Patients had treated by other clinical trial medicines or participated into other trials in 30 days
* Patients had active infections
* Any clinical problems out of control
* Women in pregnancy and lactation, Subjects with no compliance.
18 Weeks
75 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Changzheng Hospital
OTHER
Lee's Pharmaceutical Limited
INDUSTRY
Responsible Party
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Other Identifiers
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ZHAOKE-2007L03540
Identifier Type: -
Identifier Source: org_study_id