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Clinical Study on Acetyl-L-Carnitine

This study has been completed.
Sponsor:
Collaborators:
Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT01526564
First received: September 14, 2010
Last updated: November 7, 2013
Last verified: February 2012

September 14, 2010
November 7, 2013
August 2008
April 2011   (final data collection date for primary outcome measure)
Changes in peripheral sensory neuropathy grades [ Time Frame: Base and eighth week ] [ Designated as safety issue: Yes ]
Changes in peripheral sensory neuropathy grades after eight weeks treatment
Same as current
Complete list of historical versions of study NCT01526564 on ClinicalTrials.gov Archive Site
  • Changes in Neuroelectrophysiological test [ Time Frame: Base and eighth week ] [ Designated as safety issue: Yes ]
    Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment
  • Changes in Cancer-related fatigue level [ Time Frame: Base and eighth week ] [ Designated as safety issue: Yes ]
    Changes in Cancer-related fatigue level after eigth weeks treatment
  • Changes in Physical Condition Score [ Time Frame: Base and eighth week ] [ Designated as safety issue: Yes ]
    Changes in Physical Condition Score after eight weeks treatment
Same as current
Not Provided
Not Provided
 
Clinical Study on Acetyl-L-Carnitine
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Peripheral Sensory Neuropathy
  • 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 Name: NICETILE
  • Drug: Placebo
    3 t.i.d, two plates per time
  • Active Comparator: ALC
    ALC
    Intervention: Drug: Acetylcarnitine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
239
July 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Weeks to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01526564
ZHAOKE-2007L03540
Yes
Lee's Pharmaceutical Limited
Lee's Pharmaceutical Limited
  • Shanghai Jiao Tong University School of Medicine
  • Shanghai Changzheng Hospital
Not Provided
Lee's Pharmaceutical Limited
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP