UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010317 |
|---|---|
| Receipt number | R000012072 |
| Scientific Title | Efficacy of olanzapine for relief of nausea with incomplete bowel obstruction in advanced cancer patient: pragmatic randomized controlled trial |
| Date of disclosure of the study information | 2013/03/26 |
| Last modified on | 2018/02/20 15:47:22 |
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Basic information
Public title
Efficacy of olanzapine for relief of nausea with incomplete bowel obstruction in advanced cancer patient: pragmatic randomized controlled trial
Acronym
Olanzapine for nausea with incomplete bowel obstruction
Scientific Title
Efficacy of olanzapine for relief of nausea with incomplete bowel obstruction in advanced cancer patient: pragmatic randomized controlled trial
Scientific Title:Acronym
Olanzapine for nausea with incomplete bowel obstruction
Region
| Japan |
Condition
Condition
Nausea with incomplete bowel obstruction
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of olanzapine for relief of nausea with incomplete bowel obstruction in advanced cancer patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Changes in the average value of nausea for 24 hours with Numeric Rating Scale (NRS)
Key secondary outcomes
Proportion of patients with average value of nausea reduced more than 30% in NRS, number of vomit, satisfaction rating and intention to continue treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A:
olanzapine (5 mg) Zydis or tablet
5mg/day (evening) orally
Interventions/Control_2
Group B:
1) metoclopramide (5 mg) tablet 30 mg/day (morning/noon/evening) orally
or
2) metoclopramide (10 mg) injectable solution 20 mg/day (intermittent or continuous) subcutaneous or drip infusion
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 with metastatic or locally advanced cancer
2) Patients with incomplete bowel obstruction due to malignant tumor
3) Patients with NRS of nausea >=4
4) Patients with nausea not due to hypercalcemia, brain hypertension or drugs
5) Patients who can take oral medication
6) Patients aged 20 or above at the time of obtaining informed consent
7) Patients who agree to participate the study with written consent under a sufficient explanation and understanding
8) Hospitalized patients
Key exclusion criteria
1) Patients received chemotherapy or radiation therapy within 28 days
2) Patients diagnosed diabetes mellitus or having history of diabetes mellitus (possibility of worsening diabetes mellitus) Diagnosis of diabetes mellitus is on the basis of 1. fasting blood sugar >=126 mg/dl, 2. 2-hour blood sugar level after 75g glucose tolerance test >=200 mg/dl or 3. random blood sugar >=200 mg/dl and HbA1c >=6.5%
3) Patients administrated with dopaminergic drugs such as phenothiazine, butyrophenone and atypical antipsychotic within 3 days
4) Patients with nasogastric tube, percutaneous endoscopic gastrostomy and percutaneous trans-esophageal gastro-tubing
5) Patients with indication of surgery or chemotherapy
6) Patients with bowel obstruction due to non malignant disease
7) Patients with complete bowel obstruction
8) Patients with signs of gastrointestinal tract perforation or sepsis
9) Patients with incidence of colic pain (paroxysmal and repetitive abdominal pain) within 48 hours
10) Patients with high risk of colic pain according to metoclopramide
11) Patients who are judged to be inappropriate for the study by the responsible researcher
12) Patients lacking in ability to make suitable decisions
13) Patients who are judged to be inappropriate for the study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Kaneishi |
Organization
Japan Community Health care Organization Tokyo Shinjuku Medical Center
Division name
Department of Palliative Care Unit
Zip code
Address
5-1 Tsukudo-cho, Shinjuku-ku, Tokyo 162-8543, Japan
TEL
03-3269-8111
kaneishi@tkn-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Kaneishi |
Organization
Japan Community Health care Organization Tokyo Shinjuku Medical Center
Division name
Department of Palliative Care Unit
Zip code
Address
5-1 Tsukudo-cho, Shinjuku-ku, Tokyo 162-8543, Japan
TEL
03-3269-8111
Homepage URL
http://www.jortc.jp/
kaneishi@tkn-hosp.gr.jp
Sponsor or person
Institute
Non-Profit Organization JORTC
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Agency for Medical Research and Development
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
| 2013 | Year | 03 | Month | 26 | 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
| 2012 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | 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
| 2013 | Year | 03 | Month | 26 | Day |
Last modified on
| 2018 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012072
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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