UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031381
Receipt number 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 09:15:17

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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 or person

Institute

National Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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