UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015288 |
|---|---|
| Receipt number | R000017782 |
| Scientific Title | Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2014/09/30 |
| Last modified on | 2019/04/03 09:12:04 |
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Basic information
Public title
Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease
Acronym
Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease
Scientific Title
Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the efficacy of morphine for dyspnea in patients with COPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dyspnea NRS change between before (Day 0 evening) and after morphine treatment (Day 2 evening)
Key secondary outcomes
1. Dyspnea NRS change between before (Day 0 morning) and after morphine treatment (Day 1 morning, Day 2 morning)
2. Dyspnea NRS change between before (Day 0 evening) and after morphine treatment (Day1 evening).
3. Respiratory rate, blood puressure, SpO2
4. Sleep disturbance
5. Nausea NRS, Somnolence NRS, Anorexia NRS,
6. Nausea and constipation grade in CTCAE v4.0
7. Sedation
8. Derilium
9. Other adverse effect
10. Spontaneous bowel movement
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
Oral morphine 3mg or 2mg every 6 hours (total six times)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hospitalized patients with diagnosis of COPD based on the criteria of GOLD 2014 (FEV1/FVC<70%)
2. Patients with severe dyspnea at rest after standard treatment for dypnea
3. Patients aged 40 years-old or older at the time of obtaining informed consent
4. Patients with history of cigarette smoking of at least 10 pack-years
5. Patients who have the following data at baseline:
AST <= 100 IU/L
ALT <= 100 IU/L
T-BIL <= 2.0 mg/dL
eGFR >= 30 mL/min
SPO2 >= 90 % (Oxygen is allowed)
PaCO2 <= 60 Torr (Oxygen is allowed)
6. Patients who receive enough other treatment fo dyspnea of COPD
7. Patients with expected survival of 1 month or longer
8. Patients with lucidity and capability of communication and without cognitive inpairments
9. 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. Patients who did not use codein within 3 days before study entry are eligble.
3. Patients with COPD acute exacerbation
4. Patients with active infection that causes dyspnea
5. Patients with lung cancer that causes dyspnea
6. Patients with pneumothorax
7. Patients who uses invasive positive airway pressure ventilation. Patients who uses nasal high flow were not excluded
8. Patients who changed the way of intaking of bronchodilators, corticosteroids, vasodilators and anxiolytics within two days before enrollment of the study
9. Patients who have or had drug abuse or drug dependence
10. Patients who are pregnant or possibly pregnant
11. Patients who are judged to be innapropriate for the study by the physician
Target sample size
35
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
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 09 | Month | 30 | 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 | 08 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 30 | Day |
Last modified on
| 2019 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017782
