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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010317
Receipt No. 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

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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
Email 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/
Email kaneishi@tkn-hosp.gr.jp

Sponsor
Institute Non-Profit Organization JORTC
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012072

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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