UMIN-CTR Clinical Trial

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

Dyspnea in patients with interstitial lung disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

ymatsuda@kch.hosp.go.jp

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

Email

ymatsuda@kch.hosp.go.jp

Institute

Non-Profit Organization JORTC

Institute

Department

Personal name

Organization

Japanese Society for Palliative Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

01

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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