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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029459
Receipt No. R000033597
Scientific Title Study on the effect of Naldemedine Tosilate by diet
Date of disclosure of the study information 2017/10/10
Last modified on 2019/03/12

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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
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
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

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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