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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031381
Receipt No. R000035834
Scientific Title PHarmacological Audit study of Safety and Effectiveness in Real world: Naldemedine for Opioid-Induced Constipation study
Date of disclosure of the study information 2018/03/01
Last modified on 2019/04/03

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Basic information
Public title PHarmacological Audit study of Safety and Effectiveness in Real world: Naldemedine for Opioid-Induced Constipation study
Acronym Phase-R OIC study
Scientific Title PHarmacological Audit study of Safety and Effectiveness in Real world: Naldemedine for Opioid-Induced Constipation study
Scientific Title:Acronym Phase-R OIC study
Region
Japan

Condition
Condition opioid-induced constipation
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the safety and effectiveness of naldemedine for patients with cancer and opioid-induced constipation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Spontaneous bowel movements within 24 hours after first naldemedine administration
Key secondary outcomes Number of spontaneous bowel movements during 1 week after first naldemedine administration

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) adult patients with cancer receiving care from palliative care teams or in palliative care units
2) scheduled naldemedine administration for opioid-induced constipation
3) planned to receive sustained doses of opioid and laxatives
Key exclusion criteria 1) patients with suspected malignant bowel obstruction, or previous history of malignant bowel obstruction and high recurrence risk
2) prior naldemedine administration
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Shimizu
Organization National Cancer Center
Division name Department of Palliative Medicine
Zip code
Address 5-1-1 Tsukiji Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email masshimi@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Ariyoshi
Organization JORTC Data Center
Division name Department of Data Management
Zip code
Address 2-54-6-302 Nishinippori, Arakawa-ku, Tokyo, Japan
TEL 03-5604-9850
Homepage URL
Email keisuke.ariyoshi@jortc.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 03 Month 01 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
2018 Year 02 Month 28 Day
Date of IRB
2018 Year 04 Month 17 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Safety and effectiveness of naldemedine for opioid-induce constipation will be evaluated at Day 7.

Management information
Registered date
2018 Year 02 Month 20 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035834

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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