UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015898
Receipt number R000018506
Scientific Title Special Drug Use-results Survey for Long-term Administration of Durotep MT Patch 2.1mg/ 4.2mg/ 8.4mg/ 12.6mg/ 16.8mg
Date of disclosure of the study information 2014/12/15
Last modified on 2019/03/06 11:07:18

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Basic information

Public title

Special Drug Use-results Survey for Long-term Administration of Durotep MT Patch 2.1mg/ 4.2mg/ 8.4mg/ 12.6mg/ 16.8mg

Acronym

Special Drug Use-results Survey for Long-term Administration of Durotep MT Patch 2.1mg/ 4.2mg/ 8.4mg/ 12.6mg/ 16.8mg

Scientific Title

Special Drug Use-results Survey for Long-term Administration of Durotep MT Patch 2.1mg/ 4.2mg/ 8.4mg/ 12.6mg/ 16.8mg

Scientific Title:Acronym

Special Drug Use-results Survey for Long-term Administration of Durotep MT Patch 2.1mg/ 4.2mg/ 8.4mg/ 12.6mg/ 16.8mg

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 Durotep MT Patch 2.1mg/ 4.2mg/ 8.4mg/ 12.6mg/ 16.8mg.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety (Adverse Drug Reaction)
Effectiveness

Key secondary outcomes

Effeciveness (Visual Analog Scale)


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



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 Durotep MT Patch for the first time.

Key exclusion criteria

NA

Target sample size

500


Research contact person

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

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 or person

Institute

Janssen Pharmaceutical K.K.

Institute

Department

Personal name



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

2010 Year 02 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 26 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018506


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name