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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011067
Receipt No. R000012952
Scientific Title Evaluation of efficacy and safety of opioid analgesics for patients with cancer pain
Date of disclosure of the study information 2013/06/28
Last modified on 2013/06/28

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Basic information
Public title Evaluation of efficacy and safety of opioid analgesics for patients with cancer pain
Acronym Evaluation of opioid analgesics for cancer pain
Scientific Title Evaluation of efficacy and safety of opioid analgesics for patients with cancer pain
Scientific Title:Acronym Evaluation of opioid analgesics for cancer pain
Region
Japan

Condition
Condition Thoracic Malignancy
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aime of this study is to evaluate the efficacy and safety of switch from oral oxycodone less than 20mg/day to fentanyl matrix patch 2.1mg/3days(releasing rate 12.5mcg/h).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes patients' global assessment scores
Key secondary outcomes pain intensity, adverse effects and use of rescue oxycodone

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 Conversion from oral oxycodone to application of 3-day fentanyl matrix patch for consective 15 days
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) confirmed diagnosis of thoracic malignancy
2) age > 20 years
3) persistent mlignancy-related pain refractory to non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen
4) numeric rating scale (NRS) for pain under 3 for at least two consecutive days by low dose (20 mg/day or less) of oral oxycodone (Oxycontine, Shionogi-Pherma, Japan)
5) Written informed consent
Key exclusion criteria 1) prior history of allergy or hypersensitivity to opioids
2) prior history of opioid abuse
3) clinically significant cardiac, renal or hepatic insufficiency
4) increased intracranial pressure or impaired cognitive function
5) active and extensive skin disease precluding application of the transdermal delivery system
6) persistent fever of 40 degrees Celsius or over
7) pregnancy, lactation and suspicion of being pregnant
8) prior use of any opioid-antagonists within 2 days before switching to fentanyl patch.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-15 Yamada-oka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3833
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Hospital
Division name Department of Respiratory Medicine
Zip code
Address
TEL 06-6879-3833
Homepage URL
Email

Sponsor
Institute Department of Respiratory Medicine, Osaka University Hospital
Institute
Department

Funding Source
Organization Department of Respiratory Medicine, Osaka University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Respiratory Medicine, Osaka Police Hospital
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 大阪大学付属病院(大阪)
大阪警察病院(大阪)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 28 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
2008 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 28 Day
Last modified on
2013 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012952

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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