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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030218
Receipt No. R000034487
Scientific Title Multicenter Prospective Trial of Efficacy of Naldemedine for Opioid-Induced Constipation in Patients with Advanced Pancreatic Cancer
Date of disclosure of the study information 2017/12/04
Last modified on 2018/02/02

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Basic information
Public title Multicenter Prospective Trial of Efficacy of Naldemedine for Opioid-Induced Constipation in Patients with Advanced Pancreatic Cancer
Acronym Efficacy of Naldemedine for Opioid-Induced Constipation.
Scientific Title Multicenter Prospective Trial of Efficacy of Naldemedine for Opioid-Induced Constipation in Patients with Advanced Pancreatic Cancer
Scientific Title:Acronym Efficacy of Naldemedine for Opioid-Induced Constipation.
Region
Japan

Condition
Condition Opioid-induced constipation
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of a peripherally acting opioid receptor antagonist, naldemedine for opioid-induced constipation (OIC) in patients with advanced pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of spontaneous bowel movement responders during the 2-week treatment period.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Naldemedine is administered orally once daily at a dose of 0.2mg/d for 14 consecutive days.
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. patients of pancreatic cancer with OIC receiving treatment by opioid for 2 weeks or more against cancer pain
2. less than three spontaneous bowel movements during a week before entry
3. patients who understand sufficiently the study to provide written informed consent
Key exclusion criteria 1. presence or suspicion of gastrointestinal stricture
2. difficult ingestion
3. allergy of naldemedine
4. severe mental illness
5. unsuitable case
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Kida
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL 81-42-778-8111
Email m-kida@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Okuwaki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL 81-42-778-8111
Homepage URL
Email kokuwaki@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Department of Gastroenterology
Institute
Department

Funding Source
Organization no organization
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
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
2017 Year 12 Month 04 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
2017 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 01 Day
Last modified on
2018 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034487

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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