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Recruitment status Completed
Unique ID issued by UMIN UMIN000015901
Receipt No. R000018509
Scientific Title Special Drug Use-results Survey for Long-term Administration of Tramcet Combination Tablets
Date of disclosure of the study information 2014/12/15
Last modified on 2019/03/06

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Basic information
Public title Special Drug Use-results Survey for Long-term Administration of Tramcet Combination Tablets
Acronym Special Drug Use-results Survey for Long-term Administration of Tramcet Combination Tablets
Scientific Title Special Drug Use-results Survey for Long-term Administration of Tramcet Combination Tablets
Scientific Title:Acronym Special Drug Use-results Survey for Long-term Administration of Tramcet Combination Tablets
Region
Japan

Condition
Condition Chronic pain
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and effectiveness under the long-term administration of Tramcet Conbination Tablets for chronic pain
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety (Adverse Drug Reaction)
Effectiveness (Efficacy)
Key secondary outcomes Effectiveness (NRS)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chronic pain who are treated with Tramcet Combination Tablet for the first time
Key exclusion criteria NA
Target sample size 1200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshiya Kato
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept
Zip code
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5478
Email tkato1@its.jnj.com

Public contact
1st name of contact person
1st name
Middle name
Last name Hirokazu Shirai
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept
Zip code
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5951
Homepage URL
Email hshirai3@ITS.JNJ.com

Sponsor
Institute Janssen Pharmaceutical K.K.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Janssen Pharmaceutical K.K.
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
Email

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
2014 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2011 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2014 Year 12 Month 10 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018509


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