UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001958 |
|---|---|
| Receipt number | R000002386 |
| Scientific Title | Clinical safety and efficacy of combination of sustained-release morphine and transdermal fentanyl patch to the dyspnea in lung cancer patients |
| Date of disclosure of the study information | 2009/06/01 |
| Last modified on | 2010/05/12 13:23:41 |
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Basic information
Public title
Clinical safety and efficacy of combination of sustained-release morphine and transdermal fentanyl patch to the dyspnea in lung cancer patients
Acronym
Clinical safety and efficacy of combination of sustained-release morphine and transdermal fentanyl patch to the dyspnea in lung cancer patients
Scientific Title
Clinical safety and efficacy of combination of sustained-release morphine and transdermal fentanyl patch to the dyspnea in lung cancer patients
Scientific Title:Acronym
Clinical safety and efficacy of combination of sustained-release morphine and transdermal fentanyl patch to the dyspnea in lung cancer patients
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We study to clarify whether the combination is effective and safe preparation of morphine sustainability, When you have a sense of cause breathing problems in lung cancer patients using the fentanyl skin patch drug for cancer pain,
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of dyspnea
Key secondary outcomes
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
administration of susteined-release morphine
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. diagnosed with lung cancer, announced that cancer patients
2. The patients age 20 or older
3. Patients are administered of transdermal fentanyl patch for cancer pains
4. Patients with dyspnea does not improve by including non-drug therapy,
oxygen.
5. A consent of patients is obtained in writing and fully explain the effects and side effects
Key exclusion criteria
1. Patients with severe cardiac dysfunction
2. Patients with severe renal or liver dysfunction
3. Patients with increased intracranial pressure
4. Patients with skin disorders such as atopic
5. Patients have a fever of more than 40 degree centigrade
6. Patients with impaired consciousness
7. Other than the orally drug (suppository drug and injection) is administered to patients by drug route of morphine
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishimura |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address
, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Sakashita |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address
TEL
078-382-5846
Homepage URL
meidai@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2009 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 11 | Day |
Last modified on
| 2010 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002386
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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