Clinical Study on Acetyl-L-Carnitine

NCT ID: NCT01526564

Last Updated: 2013-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-07-31

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 autonomic nervous dysfunction.

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 treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.

Conditions

Peripheral Sensory Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ALC

ALC

Group Type: ACTIVE_COMPARATOR

Acetylcarnitine

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3 t.i.d, two plates per time

Interventions

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

Intervention Type: DRUG

Placebo

3 t.i.d, two plates per time

Intervention Type: DRUG

Other Intervention Names

NICETILE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Weeks
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: collaborator

Lee's Pharmaceutical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ZHAOKE-2007L03540

Identifier Type: -

Identifier Source: org_study_id