UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034124 |
|---|---|
| Receipt number | 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 | 2021/03/16 12:17:27 |
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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 | Yoshiaki |
| Middle name | |
| Last name | Okamoto |
Organization
Ashiya Municipal Hospital
Division name
Department of Pharmacy
Zip code
659-0012
Address
Hyogo, Ashiya, Asahigaokacho 39-1
TEL
0797-31-2156
okamoysh@phs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Niki |
| Middle name | |
| Last name | Kazuyuki |
Organization
Osaka University/Ashiya Municipal Hospital
Division name
Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
659-0012
Address
Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL
06-6879-8250
Homepage URL
k-niki@phs.osaka-u.ac.jp
Sponsor or person
Institute
Ashiya Municipal Hospital
Institute
Department
Personal name
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
Ashiya Municipal Hospital Ethical Review Boards
Address
Hyogo, Ashiya, Asahigaokacho 39-1
Tel
0797-31-2156
k-niki@phs.osaka-u.ac.jp
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
| 2025 | 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
| 2021 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038901
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| Registered date | File name |
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