UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effect of Naldemedine Tosilate by diet
Acronym	Survey on the effect of Naldemedine Tosilate
Scientific Title	Study on the effect of Naldemedine Tosilate by diet
Scientific Title:Acronym	Survey on the effect of Naldemedine Tosilate
Region	Japan

Condition
Condition	opioid-induced constipation
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigate the effect of Naldemedine Tosilate usage and consider appropriate usage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the change amount from the baseline of the number of SBM per week due to the difference in usage and the time from oral administration to the first SBM
Key secondary outcomes	1) Change amount of NRS score 2) Change in rescue usage 3) Survey of senses by questionnaire

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Take Naldemedine Tosilate after breakfast for 1 week and wake up the next week
Interventions/Control_2	Take Naldemedine Tosilate wake up for 1 week and after breakfast the next week
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)OIC patients 1.1week SBM less than 3 times 2.one or more of the following items a)constipation with straining b)a feeling of incomplete evacuation c)Pain at defecation 2)Men and women of ages 20 to 75 years old 3)Performance status(0-2) 4)Patients taking Boiled rice as staple food. 5)A written agreement is provided.
Key exclusion criteria	1.Performance status(3-4) 2.artificial anus 3.ileus of intestine 4.patients taking specific dietary form (for example,liquid diet,etc) 5.Having regular use of Itraconazole,Fluconazole, Rifampicin,Ciclosporin 6.Patients who do not obtain written consent 7.Patients judged inappropriate by the research director
Target sample size	14

Research contact person
Last name of lead principal investigator	1st name Middle name Last name takamitsu kanai
Organization	Takasaki General Medical Center, National Hospital Organization
Division name	Department of pharmaceutical services
Zip code
Address	36, Takamatsucho, Takasaki-shi, Gunma, JAPAN
TEL	027-322-5901
Email	t-kanai3352@takasaki-hosp.jp

Public contact
1st name of contact person	1st name Middle name Last name takamitsu kanai
Organization	Takasaki General Medical Center, National Hospital Organization
Division name	Department of pharmaceutical services
Zip code
Address	36, Takamatsucho, Takasaki-shi, Gunma, JAPAN
TEL	027-322-5901
Homepage URL
Email	t-kanai3352@takasaki-hosp.jp

Sponsor
Institute	National Hospital Organization Takasaki General Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Takasaki General Medical Center
Organization
Division
Category of Funding Organization	Self funding
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 10 Month 10 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	Terminated
Date of protocol fixation	2017 Year 08 Month 24 Day
Date of IRB	2017 Year 08 Month 17 Day
Anticipated trial start date	2017 Year 09 Month 21 Day
Last follow-up date	2019 Year 03 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 10 Month 06 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033597