UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016137 |
|---|---|
| Receipt number | R000018722 |
| Scientific Title | Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease |
| Date of disclosure of the study information | 2015/01/06 |
| Last modified on | 2017/01/08 09:58:19 |
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Basic information
Public title
Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease
Acronym
Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease
Scientific Title
Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease
Scientific Title:Acronym
Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease
Region
| Japan |
Condition
Condition
Dyspnea in patients with interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the safety and recommended dose of morphine for dyspnea in patients with interstitial lung diseases.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory depression and hypotension defined in the protocol and adverse effect >= Grade 3 (CTCAE)
Key secondary outcomes
1. Dyspnea NRS change between before and after morphine treatment
2. Heart rate before and after treatment
3. PaO2 and PaCO2 before and after treatment.
4. Number of vomitting
5. Derilium
6. Sedation
7. Adverse effect between 60 minutes and 24 hours after treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single subcutaneous injection of morphine 1mg or 2mg.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Inpatients with interstitial lung diseases diagnosed by more than 1 radiologist and more than 2 respiratory physicians based on clinical course, chest CT, lung function test and so on.
2. Patients with severe dyspnea at rest after standard treatment for dypnea
3. Patients who have the following data at baseline:
AST <= 100 IU/L
ALT <= 100 IU/L
T-BIL <= 2.0 mg/dL
SPO2 >= 90 % (Oxygen is allowed)
PaCO2 <= 50 Torr (Oxygen is allowed)
4. Patients aged 20 years-old or older at the time of obtaining informed consent
5. Patients with expected survival of 1 month or longer
6. Patients with lucidity and capability of communication and without cognitive inpairments
7. Patients who agree to participate the study with written informed consent
Key exclusion criteria
1. Patients with contraindication of morphine (ex. allergy for morphine and history of severe adverse effects of morphine)
2. Patients who use opioid
3. Patients with left heart failure by echocardiography.
4. Patients with acute respiratory failure ( bacterial pneumonia, acute excerbation of interstitial pneumonia and so on).
5. Patients with active infection that causes dyspnea
6. Patients with lung cancer that causes dyspnea
7. Patients with pneumothorax
8. Patients who uses invasive positive airway pressure ventilation. Patients who uses nasal high flow were not excluded
9. Patients who changed the way of intaking of corticosteroids, immunosuppressant, bronchodilators, vasodilators and anxiolytics within two days before enrollment of the study
10. Patients who have or had drug abuse or drug dependence
11. Patients who are pregnant or possibly pregnant
12. Patients who are judged to be innapropriate for the study by the physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Matsuda |
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Division name
Department of Psychosomatic Internal Medicine
Zip code
Address
1180 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8555, Japan
TEL
072-252-3021
ymatsuda@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Matsuda |
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Division name
Department of Psychosomatic Internal Medicine
Zip code
Address
1180 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8555, Japan
TEL
072-252-3021
Homepage URL
ymatsuda@kch.hosp.go.jp
Sponsor or person
Institute
Non-Profit Organization JORTC
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 06 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | 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
| 2015 | Year | 01 | Month | 06 | Day |
Last modified on
| 2017 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018722
