Acetylcarnitine
DrugAdministration 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
Other names: NICETILE
NCT Number: NCT01526564
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 autonomic nervous dysfunction.
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Notify Me18 week–75 year
All sexes
Interventional
Phase 3
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 treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: NICETILE
3 t.i.d, two plates per time
Time frame: Base and eighth week
Changes in peripheral sensory neuropathy grades after eight weeks treatment
Time frame: Base and eighth week
Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment
Time frame: Base and eighth week
Changes in Cancer-related fatigue level after eigth weeks treatment
Time frame: Base and eighth week
Changes in Physical Condition Score after eight weeks treatment
Lee's Pharmaceutical Limited
Industry
Phase III Study of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablets in Treatment of Peripheral Sensory Neuropathy in Anti-cancer Chemotherapeutics Induce
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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