UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006429 |
|---|---|
| Receipt number | R000007629 |
| Scientific Title | Study the efficacy and safety of fentanyl patches on QOL/ADL in patients with chronic pain |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2014/04/01 16:36:19 |
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Basic information
Public title
Study the efficacy and safety of fentanyl patches on QOL/ADL in patients with chronic pain
Acronym
Study of efficacy and safety of fentanyl patches for chronic pain.
Scientific Title
Study the efficacy and safety of fentanyl patches on QOL/ADL in patients with chronic pain
Scientific Title:Acronym
Study of efficacy and safety of fentanyl patches for chronic pain.
Region
| Japan |
Condition
Condition
patients with chronic pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of fentanyl patch on QOL/ADL in patients with chronic pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
VAS: Visual Analogue Scale
Key secondary outcomes
SF-36
Patient satisfaction (at the end of the test is performed out of 5)
Adverse event
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
Durotep MT patch
6 weeks
2.1mg~16.8mg
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
Patients over 20 years of age
Written informed conscent to receive this therapy
Visual Analog Scale of pain intensity felt in daily life of an average in patients over 40mm
Key exclusion criteria
Patients with hypersensitivity to opioids
Patients with a history of opioid abuse
Patients with respiratory dysfunction such as chronic lung disease
Patients with asthma
Patients with severe cardiac dysfunction
Patients with severe liver and renal dysfunction
Intracranial hypertension, patients with impaired consciousness
Eczema at the site of drug patch testing, patients with atopic dermatitis, etc.
Patients with fever above 40 degree was observed
Pregnant women, patients might have been pregnant or nursing mothers
Within two days before starting the test, patients who are scheduled to be administered to patients receiving an opioid receptor antagonist such as pentazocine or buprenorphine.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Hasegawa |
Organization
Kawasaki Medical School
Division name
Department of Orthopedics, Traumatology and Spine Surgery
Zip code
Address
577 Matsushima Kurashiki city,Okayama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Hasegawa |
Organization
Kawasaki Medical School
Division name
Department of Orthopedics, Traumatology and Spine Surgery
Zip code
Address
577 Matsushima Kurashiki city,Okayama
TEL
Homepage URL
Sponsor or person
Institute
Kawasaki Medical School,Department of Orthopedics, Traumatology and Spine Surgery
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 28 | Day |
Last modified on
| 2014 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007629
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
