UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018147 |
|---|---|
| Receipt number | R000020974 |
| Scientific Title | Evaluation of tramadol / acetaminophen combination tablets to evaluate the effectiveness of analgesic treatment in cancer patients who had the symptomatic chemotherapy induced peripheral neuropathy. |
| Date of disclosure of the study information | 2015/07/02 |
| Last modified on | 2016/12/31 10:01:06 |
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Basic information
Public title
Evaluation of tramadol / acetaminophen combination tablets to evaluate the effectiveness of analgesic treatment in cancer patients who had the symptomatic chemotherapy induced peripheral neuropathy.
Acronym
Tramcet for CIPN
Scientific Title
Evaluation of tramadol / acetaminophen combination tablets to evaluate the effectiveness of analgesic treatment in cancer patients who had the symptomatic chemotherapy induced peripheral neuropathy.
Scientific Title:Acronym
Tramcet for CIPN
Region
| Japan |
Condition
Condition
Chemotherapy induced peripheral neuropathy
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of tramadol / acetaminophen combination tablets in cancer patients who had peripheral neuropathy induced by platinum or taxane agent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Numerical rating scale of numbness four weeks later after an internal use of tramadol / acetaminophen combination tablets starts.
Key secondary outcomes
Functional Assessment of Cancer Therapy- Neurotoxicity (FACT-NTX)
Neuropathic Pain Symptom Inventory (NPSI)
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tramadol / acetaminophen combination tablet is administered orally twice a day at one tablet for the first 7 days. For the following 21 days, it is administered orally four times a day at one tablet, after each meal and before sleeping.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The patients who previously recieved or are recieving the chemotherapy with platinum agents(oxaliplatin,cisplatin) or taxane are clinically diagnosed as chemotherapy induced peripheral neuropathy(CIPN).
2)For 2 weeks and more, continuation of CIPN of grade2 or 3 in CTCAE v4.0.
3)After a start of the clinical trial, it is anticipated that there are not cancellation of the chemotherapy, a regimen change for at least four weeks.
4)A drug, the dose of the pain-killer (NSAIDs, opioid) did not have a change within four weeks before registration.
Key exclusion criteria
1)In taking acetaminophen or tramadol component.
2)Opioids is cotraindicated.
3)Acetaminophen is contraindicated.
4)The patient that antidepressant, an antiepileptic drug, antiarrhythmic, pregabalin, Goshajinkigan were started within four weeks from registration.
5)Peripheral neuropathy induced by diabetes, alcohol and drugs except platinum agents and taxane.
6)Taking selegiline hydrochloride.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Naruge |
Organization
School of Medicine, Kyorin University
Division name
Department of Internal Medicine, Medical Oncology
Zip code
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL
0422-47-5511
ecg777@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Naruge |
Organization
School of Medicine, Kyorin University
Division name
Department of Internal Medicine, Medical Oncology
Zip code
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL
0422-47-5511
Homepage URL
ecg777@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Medical Oncology, School of Medicine, Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Janssen pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2016 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020974
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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