Clinical Study on Acetyl-L-Carnitine

November 7, 2013 updated by: Lee's Pharmaceutical Limited

Phase III Study of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablets in Treatment of Peripheral Sensory Neuropathy in Anti-cancer Chemotherapeutics Induce

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 73 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
3 t.i.d, two plates per time
Active Comparator: ALC
Drug: 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
Other Names:
  • NICETILE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in peripheral sensory neuropathy grades
Time Frame: Base and eighth week
Changes in peripheral sensory neuropathy grades after eight weeks treatment
Base and eighth week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Neuroelectrophysiological test
Time Frame: Base and eighth week
Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment
Base and eighth week
Changes in Cancer-related fatigue level
Time Frame: Base and eighth week
Changes in Cancer-related fatigue level after eigth weeks treatment
Base and eighth week
Changes in Physical Condition Score
Time Frame: Base and eighth week
Changes in Physical Condition Score after eight weeks treatment
Base and eighth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lee's Pharmaceutical Limited

Collaborators

Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

February 1, 2012

First Posted (Estimate)

February 6, 2012

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZHAOKE-2007L03540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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