UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of tramadol / acetaminophen combination tablets to evaluate the effectiveness of analgesic treatment in cancer patients who had the symptomatic chemotherapy induced peripheral neuropathy.
Title of the study (Brief title)	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	Daisuke Naruge
Organization	School of Medicine, Kyorin University
Division name	Department of Internal Medicine, Medical Oncology
Address	6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL	0422-47-5511
Email	ecg777@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Daisuke Naruge
Organization	School of Medicine, Kyorin University
Division name	Department of Internal Medicine, Medical Oncology
Address	6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL	0422-47-5511
Homepage URL
Email	ecg777@ks.kyorin-u.ac.jp

Sponsor
Institute	Department of Internal Medicine, Medical Oncology, School of Medicine, Kyorin University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020974