UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030218 |
|---|---|
| Receipt number | 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 | 2021/02/04 11:52:39 |
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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 | Mitsuhiro |
| Middle name | |
| Last name | Kida |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
81-42-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
81-42-778-8111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Department of Gastroenterology
Institute
Department
Personal name
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
Institutional Ethics Committee of Kitasato University
Address
81-42-778-8111
Tel
81-42-778-8111
rinri@med.kitasato-u.ac.jp
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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
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
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034487
