UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease
Title of the study (Brief title)	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	Yoshinobu Matsuda
Organization	National Hospital Organization Kinki-Chuo Chest Medical Center
Division name	Department of Psychosomatic Internal Medicine
Address	1180 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8555, Japan
TEL	072-252-3021
Email	ymatsuda@kch.hosp.go.jp

Public contact
Name of contact person	Yoshinobu Matsuda
Organization	National Hospital Organization Kinki-Chuo Chest Medical Center
Division name	Department of Psychosomatic Internal Medicine
Address	1180 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8555, Japan
TEL	072-252-3021
Homepage URL
Email	ymatsuda@kch.hosp.go.jp

Sponsor
Institute	Non-Profit Organization JORTC
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018722