UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study on the efficacy and safety of continuous subcutaneous hydromorphone titration for cancer pain
Acronym	A retrospective study on continuous subcutaneous hydromorphone titration for cancer pain
Scientific Title	A retrospective study on the efficacy and safety of continuous subcutaneous hydromorphone titration for cancer pain
Scientific Title:Acronym	A retrospective study on continuous subcutaneous hydromorphone titration for cancer pain
Region	Japan

Condition
Condition	Moderate or severe, uncontrollable cancer pain.
Classification by specialty	Geriatrics Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the efficacy and safety of the continuous subcutaneous hydromorphone titration for cancer pain retrospectively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Completion rate of titration.
Key secondary outcomes	Time to completion of titration; response rate; effect on other symptoms including dyspnea; adverse events.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous subcutaneous injection of hydromorphone.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Moderate or severe, uncontrollable cancer pain.
Key exclusion criteria	None.
Target sample size	79

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Kajiyama
Organization	The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name	Department of palliative care
Zip code	530-8480
Address	2-4-20, Ougi-machi, Kita-ku, Osaka, Japan
TEL	06-6312-1221
Email	t-kajiyama@kitano-hp.or.jp

Public contact
Name of contact person	1st name Tatsuma Middle name Last name Sakaguchi
Organization	The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name	Department of palliative care
Zip code	530-8480
Address	2-4-20, Ougi-machi, Kita-ku, Osaka, Japan
TEL	06-6312-1221
Homepage URL
Email	t-sakaguchi@kitano-hp.or.jp

Sponsor
Institute	The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department

Funding Source
Organization	The Tazuke Kofukai Medical Research Institute, Kitano Hospital
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	The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Address	2-4-20, Ougi-machi, Kita-ku, Osaka, Japan
Tel	06-6312-1221
Email	t-sakaguchi@kitano-hp.or.jp

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	公益財団法人田附興風会医学研究所北野病院

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 16 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	37
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	2021 Year 11 Month 17 Day
Date of IRB	2021 Year 12 Month 15 Day
Anticipated trial start date	2021 Year 12 Month 15 Day
Last follow-up date	2021 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 12 Month 16 Day
Last modified on	2021 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052396