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


Phase 3
18 Weeks
75 Years
Not Enrolling
Both
Peripheral Sensory Neuropathy

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Trial Information

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


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.


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
- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Changes in peripheral sensory neuropathy grades

Outcome Description:

Changes in peripheral sensory neuropathy grades after eight weeks treatment

Outcome Time Frame:

Base and eighth week

Safety Issue:

Yes

Authority:

China: Food and Drug Administration

Study ID:

ZHAOKE-2007L03540

NCT ID:

NCT01526564

Start Date:

May 2009

Completion Date:

May 2010

Related Keywords:

  • Peripheral Sensory Neuropathy
  • Chemotherapy-induced peripheral neuropathy (CIPN)

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