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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042357
Receipt No. R000048352
Scientific Title OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Date of disclosure of the study information 2020/11/05
Last modified on 2021/01/07

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Basic information
Public title OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Acronym OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Scientific Title OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Scientific Title:Acronym OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Region
Japan

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

Objectives
Narrative objectives1 To Collect the safety information of OxyContin TR tablets at dose reduction and at the end of administration (discontinuation) in patients with chronic pain under the actual conditions of use, and evaluate the frequency of the incidence for physiccal dependence and/or the increasing risks for dependence during long term use
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Safety
evaluating drug dependency
Key secondary outcomes (1) Safety
Incidence rates of adverse drug reactions
(2) Efficacy
Clinical Global Impression-Improvement (CGI-I)
Brief Pain Inventory-Severity of pain, funactional impairment

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 who received OxyContin TR tablets for the first time to relieve chronic pain.
Key exclusion criteria NA
Target sample size 350

Research contact person
Name of lead principal investigator
1st name Toshihiro
Middle name
Last name Shinosaki
Organization Shionogi Pharma Co., Ltd.
Division name Pharmacovigilance Department
Zip code 566-0022
Address 5-1, Mishima 2-chome, Settsu, Osaka 566-0022, Japan
TEL 06-6381-7103
Email toshihiro.shinosaki@shionogi.co.jp

Public contact
Name of contact person
1st name Yoshinori
Middle name
Last name Kitano
Organization Shionogi Pharma Co., Ltd.
Division name Pharmacovigilance Department
Zip code 566-0022
Address 5-1, Mishima 2-chome, Settsu, Osaka 566-0022, Japan
TEL 06-6381-7103
Homepage URL
Email yoshinori.kitano@shionogi.co.jp

Sponsor
Institute Shionogi Pharma Co., Ltd.
Institute
Department

Funding Source
Organization Shionogi Pharma Co., Ltd.
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 None
Address None
Tel None
Email None

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
2020 Year 11 Month 05 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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 07 Day
Date of IRB
2020 Year 10 Month 07 Day
Anticipated trial start date
2020 Year 12 Month 04 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2020 Year 11 Month 05 Day
Last modified on
2021 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048352

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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