UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000060080
Receipt number R000068712
Scientific Title Prophylactic use of constipation drugs for prevention of opioidinduced constipation in patients with opioid starting: a systematic review and meta-analysis
Date of disclosure of the study information 2025/12/14
Last modified on 2025/12/14 16:35:24

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Basic information

Public title

Prophylactic use of constipation drugs for prevention of opioidinduced
constipation in patients with opioid starting: a systematic
review and meta-analysis

Acronym

Prophylactic use of constipation drugs for prevention of opioidinduced
constipation in patients with opioid starting: a systematic
review and meta-analysis

Scientific Title

Prophylactic use of constipation drugs for prevention of opioidinduced
constipation in patients with opioid starting: a systematic
review and meta-analysis

Scientific Title:Acronym

Prophylactic use of constipation drugs for prevention of opioidinduced
constipation in patients with opioid starting: a systematic
review and meta-analysis

Region

Japan


Condition

Condition

Patients with opioid starting

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We conducted a systematic review and meta-analysis on the prophylactic use of naldemedine for the prevention of opioid-induced constipation in patients initiating opioid therapy.

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

a systematic review, meta-analysis

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with opioid starting

Key exclusion criteria

none

Target sample size



Research contact person

Name of lead principal investigator

1st name Takaomi
Middle name
Last name Kessoku

Organization

IUHW Narita hospital

Division name

Palliative medicine and Gastroenterology

Zip code

286-8520

Address

852, Hatakeda, Narita, Chiba, Japan

TEL

0476355600

Email

takaomi0027@gmail.com


Public contact

Name of contact person

1st name Takaomi
Middle name
Last name Kessoku

Organization

International university of health and welfare Narita hospital

Division name

Palliative medicine and Gastroenterology

Zip code

286-8520

Address

852, Hatakeda, Narita, Chiba, Japan

TEL

0476355600

Homepage URL


Email

takaomi0027@gmail.com


Sponsor or person

Institute

IUHW

Institute

Department

Personal name



Funding Source

Organization

Self

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

NA

Address

NA

Tel

NA

Email

NA


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

2025 Year 12 Month 14 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

Preinitiation

Date of protocol fixation

2025 Year 12 Month 14 Day

Date of IRB


Anticipated trial start date

2026 Year 01 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

syastematic review, metaanalysis
P: Patients with opioid starting
I: Constipation drugs (based on drugs)
C: no constipation drugs
O: Constipation preventon


Management information

Registered date

2025 Year 12 Month 14 Day

Last modified on

2025 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068712