Peripheral Sensory NeuropathyPhase 3NCT01526564
Clinical Study on Acetyl-L-Carnitine
A Phase 3 study testing Acetylcarnitine in people with Peripheral Sensory Neuropathy, run by Lee's Pharmaceutical Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 weeks to 75 years
- Conditions the study is for
- Peripheral Sensory Neuropathy
- What is being tested?
- Acetylcarnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 weeks to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- At least one of the neuroelectrophysiological examine results were abnormal
- Physical Condition Score (KPS) >/=60
- Anticipated lifetime>/=60.
Who cannot join
- 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
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- Patients had active infections
- Any clinical problems out of control
- Women in pregnancy and lactation, Subjects with no compliance.
About this study
Official title: 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.
Read the 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
- Being tested
- Acetylcarnitine, Placebo
- Keywords
- Chemotherapy-induced peripheral neuropathy (CIPN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcarnitineDrug
Also called NICETILE
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
PlaceboDrug
3 t.i.d, two plates per time
| Study group | Role | What they receive |
|---|---|---|
| ALC | Active comparator | ALC Receives: Drug: Acetylcarnitine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peripheral sensory neuropathy grades
Changes in peripheral sensory neuropathy grades after eight weeks treatment
Measured: Base and eighth week
Secondary outcomes (3)
Changes in Neuroelectrophysiological test
Changes in Neuroelectrophysiological test after eight weeks ALC or placebo treatment
Measured: Base and eighth week
Changes in Cancer-related fatigue level
Changes in Cancer-related fatigue level after eigth weeks treatment
Measured: Base and eighth week
Changes in Physical Condition Score
Changes in Physical Condition Score after eight weeks treatment
Measured: Base and eighth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startAug 2008
- Primary completionApr 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Sensory NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526564
- Sponsor's protocol ID
- ZHAOKE-2007L03540
- Status last verified
- Feb 2012
- First submitted
- 14 Sep 2010
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablets in Treatment of Peripheral Sensory Neuropathy in Anti-cancer Chemotherapeutics Induce
- ClinicalTrials.gov ID
- NCT01526564
- Acronym / sponsor ID
- ZHAOKE-2007L03540
- Conditions
- Peripheral Sensory Neuropathy
- Keywords
- Chemotherapy-induced peripheral neuropathy (CIPN)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital
- Study start
- Aug 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALC | Active comparator | Drug: AcetylcarnitineALC |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 weeks to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetylcarnitineAlso: NICETILEAdministration 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 | Drug | ALC |
| Placebo3 t.i.d, two plates per time | Drug | Placebo |
Primary outcome
Changes in peripheral sensory neuropathy grades
Time frame: Base and eighth week
Changes in peripheral sensory neuropathy grades after eight weeks treatment
3 secondary outcomes
Changes in Neuroelectrophysiological test
Time frame: Base and eighth week
Changes in Cancer-related fatigue level
Time frame: Base and eighth week
Changes in Physical Condition Score
Time frame: Base and eighth week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylcarnitine in people with Peripheral Sensory Neuropathy, run by Lee's Pharmaceutical Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in peripheral sensory neuropathy grades (time frame: Base and eighth week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.