UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049267 |
|---|---|
| Receipt number | R000056106 |
| Scientific Title | PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Dyspnea in Patients with Non-malignant Respiratory Diseases Study |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2022/10/19 21:46:05 |
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Basic information
Public title
PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Dyspnea in Patients with Non-malignant Respiratory Diseases Study
Acronym
PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Dyspnea in Patients with Non-malignant Respiratory Diseases Study
Scientific Title
PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Dyspnea in Patients with Non-malignant Respiratory Diseases Study
Scientific Title:Acronym
PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Dyspnea in Patients with Non-malignant Respiratory Diseases Study
Region
| Japan |
Condition
Condition
Non-malignant respiratory diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness and safety of regular opioid administration for dyspnea in patients with non-malignant respiratory diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of patients with at least 1 decrease in dyspnea NRS 24 hours after initiation of regular opioid therapy
Key secondary outcomes
Percentage of patients with dyspnea IPOS of 1 or less 24 hours after starting regular opioid therapy for dyspnea
Change in dyspnea NRS (now) 24 hours after starting regular opioids for dyspnea
Change in dyspnea NRS (worst value in previous 24 hours) in 24 hours after starting regular opioids for dyspnea
Percentage of improvement in dyspnea by patient subjective measures 24 hours after starting regular opioids for dyspnea
Opioid-related adverse events in the first 24 hours after starting regular opioids for dyspnea
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hospitalized adult patients with non-malignant respiratory diseases
2. Patients who will receive regular opioids (morphine, codeine, oxycodone, hydromorphone, fentanyl) for dyspnea (IPOS > 1 in the past day)
Key exclusion criteria
1. Patients who are scheduled to undergo an intervention (e.g., chest drainage of pneumothorax or pleural effusion, introduction or withdrawal of noninvasive respiratory management techniques such as NPPV or HFNC) that could cause a change in dyspnea intensity within 2 days of enrollment
2. Patients on invasive ventilation
3. Patients with malignant tumors in the thoracic cavity
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Matsuda |
Organization
National Hospital Organization Kinki-Chuso Chest Medical Center
Division name
Department of Psychosomatic Internal Medicine
Zip code
591-8555
Address
Nagasone-Cho 1180, Kita-ku, Sakai city, Osaka, 591-8555, Japan
TEL
0722523021
matsuda.yoshinobu.tx@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Matsuda |
Organization
National Hospital Organization Kinki-Chuso Chest Medical Center
Division name
Department of Psychosomatic Internal Medicine
Zip code
591-8555
Address
Nagasone-Cho 1180, Kita-ku, Sakai city, Osaka, 591-8555, Japan
TEL
0722523021
Homepage URL
matsuda.yoshinobu.tx@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kinki-Chuso Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kinki-Chuso Chest Medical Center
Address
Nagasone-Cho 1180, Kita-ku, Sakai city, Osaka, 591-8555, Japan
Tel
0722523021
matsuda.yoshinobu.tx@mail.hosp.go.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
| 2022 | Year | 10 | Month | 19 | 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
Suspended
Date of protocol fixation
| 2022 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special note
Management information
Registered date
| 2022 | Year | 10 | Month | 19 | Day |
Last modified on
| 2022 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056106
