UMIN-CTR Clinical Trial

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
Last 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
1st 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