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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034124
Receipt No. R000038901
Scientific Title Comparative test of morphine hydrochloride internal solution and hydromorphone hydrochloride tablets on idiopathic dyspnea
Date of disclosure of the study information 2018/09/14
Last modified on 2019/09/14

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Basic information
Public title Comparative test of morphine hydrochloride internal solution and hydromorphone hydrochloride tablets on idiopathic dyspnea
Acronym Comparative test of morphine hydrochloride internal solution and hydromorphone hydrochloride tablets on idiopathic dyspnea
Scientific Title Comparative test of morphine hydrochloride internal solution and hydromorphone hydrochloride tablets on idiopathic dyspnea
Scientific Title:Acronym Comparative test of morphine hydrochloride internal solution and hydromorphone hydrochloride tablets on idiopathic dyspnea
Region
Japan

Condition
Condition Idiopathic dyspnea
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of hydromorphone release formulation on idiopathic dyspnea.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NRS for respiratory distress (45 minutes after administration)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 Morphine hydrochloride solution or hydromorphone hydrochloride tablet should be taken when the subject feels sudden breathing difficulty. As soon as subjects take either of them, subjects will be evaluated the degree of breathing difficulty, respiratory rate, presence or absence of cyanosis, SpO 2 every 15 minutes from the time of ingestion to 1 hour. The dosage is set to 5 mg for morphine hydrochloride solution and 1 mg for hydromorphone hydrochloride tablet. If subjects feel sudden breathing difficulty 4 hours or more after initial administration, subjects should take another of them. After that, the degree of respiratory difficulty, the respiratory rate, the presence or absence of cyanosis, SpO 2 is evaluated every 15 minutes from the time of taking the dose by 1 hour after the administration in the same procedure as in the first administration.
Interventions/Control_2 Morphine hydrochloride solution or hydromorphone hydrochloride tablet should be taken when the subject feels sudden breathing difficulty. As soon as subjects take either of them, subjects will be evaluated the degree of breathing difficulty, respiratory rate, presence or absence of cyanosis, SpO 2 every 15 minutes from the time of ingestion to 1 hour. The dosage is set to 5 mg for morphine hydrochloride solution and 1 mg for hydromorphone hydrochloride tablet. If subjects feel sudden breathing difficulty 4 hours or more after initial administration, subjects should take another of them. After that, the degree of respiratory difficulty, the respiratory rate, the presence or absence of cyanosis, SpO 2 is evaluated every 15 minutes from the time of taking the dose by 1 hour after the administration in the same procedure as in the first administration.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Over 18 years old
2.People who show exacerbation of dyspnea and exacerbation of uncomfortable feeling, which exceeds the range of dyspnea normally experienced by patients
3.Dyspnea intensities average on average Numeric rating scale (NRS) >= 3
4.Karnofsky Performance Status >= 50
Key exclusion criteria 1.People who have a cognitive decline that can not be answered by survey forms
2.Patients with chronic obstructive pulmonary disease
3.Heart failure patients
4.Patients with severe renal impairment
5.Those receiving oxygen assistance above 6 L / min
6.Persons with drug abuse history
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Okamoto Yoshiaki
Organization Ashiya Municipal Hospital
Division name Department of Pharmacy
Zip code
Address Hyogo, Ashiya, Asahigaokacho 39-1
TEL 0797-31-2156
Email okamoysh@phs.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Niki
Organization Osaka University/Ashiya Municipal Hospital
Division name Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
Address Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL 06-6879-8250
Homepage URL
Email k-niki@phs.osaka-u.ac.jp

Sponsor
Institute Ashiya Municipal Hospital
Institute
Department

Funding Source
Organization Ashiya Municipal Hospital
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
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
2018 Year 09 Month 14 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 24 Day
Date of IRB
2018 Year 05 Month 08 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2020 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
2018 Year 09 Month 13 Day
Last modified on
2019 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038901

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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