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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038918
Receipt No. R000044364
Scientific Title PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Date of disclosure of the study information 2019/12/20
Last modified on 2021/06/19

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Basic information
Public title PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Acronym PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Scientific Title PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Scientific Title:Acronym PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Region
Japan

Condition
Condition Cancer dyspnea
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the effectiveness and safety of systemic opioid therapy for dyspnea in cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patient whose dyspnea NRS score decrease 1 point or greater 72 hours after starting regular opioid.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1) Adult (20 year or older) cancer patient
2) Inpatient
3) Starting regular opioid (morphine, oxycodone, hydromorphone, or fentanyl) for dyspnea
Key exclusion criteria 1) Treatment for non-cancer etiology of dyspnea will be planed within 3 days.
2) Treatment which has potential of improving dyspnea drastically will be planed within 3 days.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamaguchi
Organization Konan medical center
Division name Division of Palliative Care
Zip code
Address 1-15-6 Kamokogahara1, Kobe, Japan
TEL 0788512161
Email ikagoro@pop06.odn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamaguchi
Organization Konan medical center
Division name Division of Palliative Care
Zip code
Address 1-15-6 Kamokogahara, Kobe, Japan
TEL 0788512161
Homepage URL
Email ikagoro@pop06.odn.ne.jp

Sponsor
Institute Konan Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization Other
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
2019 Year 12 Month 20 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 Open public recruiting
Date of protocol fixation
2019 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 01 Month 03 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Registry of the data from daily clinical practice. Observation period will be 72 hrs period after starting regular opioid for cancer dyspnea.

Management information
Registered date
2019 Year 12 Month 18 Day
Last modified on
2021 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044364


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