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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006429
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kawasaki Medical School,Department of Orthopedics, Traumatology and Spine Surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007629

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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