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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001958
Receipt No. 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

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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
Email

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
Email meidai@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002386

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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