Status:
COMPLETED
Clinical Study on Acetyl-L-Carnitine
Lead Sponsor:
Lee's Pharmaceutical Limited
Collaborating Sponsors:
Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Conditions:
Peripheral Sensory Neuropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonom...
Detailed Description
This multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is to observe the efficacy and safety of the Acetyl-L-Carnitine Hydrochloride enteric-coated tablets in treat...
Eligibility Criteria
Inclusion
- Patients had signed the Informed Consent Form
- 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
- Patients whose peripheral sensory neuropathy was induced by medicines except of the Taxoids, Satraplatin and vincristine anti-cancer chemotherapeutics
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01526564
Start Date
August 1 2008
End Date
July 1 2011
Last Update
November 11 2013
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