UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029459 |
|---|---|
| Receipt number | 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 12:41:10 |
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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
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
t-kanai3352@takasaki-hosp.jp
Sponsor or person
Institute
National Hospital Organization Takasaki General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
