UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022172 |
|---|---|
| Receipt number | R000025546 |
| Scientific Title | Efficacy and safety of olanzapine suppositories in terminally ill patients with delirium or nausea and vomiting. |
| Date of disclosure of the study information | 2016/05/02 |
| Last modified on | 2016/05/02 12:31:52 |
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Basic information
Public title
Efficacy and safety of olanzapine suppositories in terminally ill patients with delirium or nausea and vomiting.
Acronym
Efficacy and safety of olanzapine suppositories.
Scientific Title
Efficacy and safety of olanzapine suppositories in terminally ill patients with delirium or nausea and vomiting.
Scientific Title:Acronym
Efficacy and safety of olanzapine suppositories.
Region
| Japan |
Condition
Condition
delirium, nausea and vomiting
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A new formulation of olanzapine available for terminally ill patients with oral feeding difficulties is needed. Rectal administration using suppositories is an alternative for patients for whom administration via the oral route is not feasible. So, we prepare olanzapine suppositories and evaluate the clinical efficacy and safety of olanzapine suppositories used to treat patients with delirium, vomiting, or nausea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Responses to olanzapine therapy are evaluated based on clinical assessments by physicians. Information about the side effects is extracted from the electronic medical records of each patient.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients use olanzapine suppositories as a treatment for delirium or nausea and vomiting at the time of oral feeding difficulties. Patients are administered 2.5 mg, 5 mg, and 10 mg of olanzapine suppositories.
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
We selected to treat for delirium or nausea and vomiting in terminally ill cancer patients with oral feeding difficulties.
Key exclusion criteria
We exclude children and patients with taking orally.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Miyazawa |
Organization
Shonan Central Hospital
Division name
Pharmacy
Zip code
Address
1-3-43 Hatori, Fujisawa-si, Kanagawa, Japan
TEL
0466-36-8151
miyazawa@swg.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Miyazawa |
Organization
Shonan Central Hospital
Division name
Pharmacy
Zip code
Address
1-3-43 Hatori, Fujisawa-si, Kanagawa, Japan
TEL
0466-36-8151
Homepage URL
miyazawa@swg.or.jp
Sponsor or person
Institute
Shonan Central Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Practical Pharmacy, Keio University Faculty of Pharmacy
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
| 2016 | Year | 05 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2016 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025546
