UMIN-CTR Clinical Trial

Public title

Effect of polypharmacy on tolerability of oxycodone: a multicenter retrospective observational study

Acronym

Effect of polypharmacy on tolerability of oxycodone: a multicenter retrospective observational study

Scientific Title

Effect of polypharmacy on tolerability of oxycodone: a multicenter retrospective observational study

Scientific Title:Acronym

Effect of polypharmacy on tolerability of oxycodone: a multicenter retrospective observational study

Region

Japan

Condition

Cancer patients who were prescribed oxycodone at starting dose of 10 mg - 20 mg per day.

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Pneumology	Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate effect on tolerability of oxycodone when concomitantly administered with CYP3A4 inhibitor or CYP3A4 substrate drug.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Total number of concomitant medications which are CYP3A4 inhibitor and CYP3A4 substrate.

Key secondary outcomes

(1)Total number of concomitant medications which are CYP3A4 inhibitor, CYP3A4 substrate, CYP2D6 inhibitor and CYP2D6 substrate.
(2)Risk factor of discontinuing oxycodone, reducing dose or changing to other analgesia due to adverse effect
(3)Risk factor of nausea or vomiting

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)No prior administration of opioid analgesia except tramadol.
(2)Age of at least 20 yaers.
(3)Patients who were administered oxycodone extended-release tablets at starting dose for 10 mg - 20mg.
(4)All medications administered regularly during 2 weeks after starting oxycodone hydrochloride extended-release tablets were known.
(5)Without nausea and vomiting
(6)ECOG) performance status of 0 to 2

Key exclusion criteria

(1)Patients who were titrated with oxycodone immediate-release preparations more than 1 day before starting oxycodone hydrochloride extended-release tablets
(2)Patients with symptomatic brain metastases or clinically confirmed brain metastases during the evaluation period
(3)Patients who administered cytotoxic anticancer drug or molecular targetting drug during the evaluation period from 1 week before the start of extended-release oxycodone tablets
(4)Patients had received radiotherapy to the head, abdomen, or pelvis within 6 days before and during the evaluation period.
(5)Patients with electrolyte abnormalities at the starting or around the start of oxycodone extended release tablets.

Target sample size

200

Name of lead principal investigator

1st name	Katsuya
Middle name
Last name	Makihara

Organization

Yodogawa Christian Hospital

Division name

Department of Pharmacy

Zip code

533-0024

Address

1-7-50 Kunijima, Higashiyodogawa-ku, Osaka

TEL

06-6322-2250

Email

katsuya.ych@gmail.com

Name of contact person

1st name	Katsuya
Middle name
Last name	Makihara

Organization

Yodogawa Christian Hospital

Division name

Department of Pharmacy

Zip code

533-0024

Address

1-7-50 Kunijima, Higashiyodogawa-ku, Osaka

TEL

06-6322-2250

Homepage URL

Email

katsuya.ych@gmail.com

Institute

Japanese Society for Pharmaceutical Palliative Care and Sciences

Institute

Department

Personal name

Organization

Japanese Society for Pharmaceutical Palliative Care and Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yodogawa Christian Hospital

Address

1-7-50 Kunijima, Higashiyodogawa-ku, Osaka

Tel

06-6322-2250

Email

katsuya.ych@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

253

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

Recruitment status

No longer recruiting

Date of protocol fixation

2019

Year

09

Month

01

Day

Date of IRB

2019

Year

09

Month

18

Day

Anticipated trial start date

2019

Year

10

Month

24

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The observation period is 2 weeks, and the following two groups are compared.
(1)Patients who were discontinued, reduced dose or changed to other analgesia due to adverse effects, and who were continued oxycodone without a dose reduction.
(2)Patients who experienced vomiting or added antiemetics, and who did not vomit and did not add antiemetics

Registered date

2019

Year

10

Month

27

Day

Last modified on

2021

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043738