UMIN-CTR Clinical Trial

Public title

Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan

Acronym

Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan

Scientific Title

Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan

Scientific Title:Acronym

Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan

Region

Japan

Condition

Opioid-induced constipation

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Pneumology	Hematology and clinical oncology	Surgery in general
Gastrointestinal surgery	Hepato-biliary-pancreatic surgery	Chest surgery
Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the prevalence of opioid-induced constipation (OIC) in patients with cancer pain who started opioid analgesic treatment through a prospective observational study

Basic objectives2

Others

Basic objectives -Others

prospective observational study

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Morbidity of OIC based on ROME IV diagnostic criteria

Key secondary outcomes

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) Age at the time of informed consent: 20 years or older
(2) Male and Female, inpatient and outpatient
(3) Patients who did not have previous opioid analgesic treatment
(4) Patients who are able to receive oral intake of drugs, food, and beverages
(5) Patients who are able to walk and perform daily activities without assistance: performance status (PS) between 0 and 2
(6) Patients who are able to perform a self-assessment using patient diary; the diary may be recorded by someone on behalf of the patient, on the condition that the patient is able to perform the assessment unaided.
(7) Cancer patients whose condition is expected to be stable during the observation period
(8) Patients who give written informed consent for participation in the study upon being informed about this study

Key exclusion criteria

(1) Patients who serious structural abnormalities of the gastrointestinal tract (e.g., mechanical ileus), diseases that affect bowel transit (e.g.,
(2) Patients who underwent surgery, intervention (e.g., nerve block), or radiation therapy that affects the digestive function within 28 days of the day of registration, or those who are scheduled to undergo such procedures during the observation period
(3) Patients who had two or fewer bowel movements during the 7-day period immediately prior to the day of patient registration
(4) Patients who had disimpaction within the 7-day period immediately before the day of registration, or are scheduled to undergo the procedure during the observation period
(5) Patients with artificial anus
(6) Patients who are consideredineligiblethe study by the physician based on concomitant therapies or medical findings

Target sample size

220

Name of lead principal investigator

1st name
Middle name
Last name	Akihiro Tokoro

Organization

National Hospital Organization Kinki-chuo Chest Medical Center

Division name

Department of psychosomatic medicine/ Palliative care team

Zip code

Address

1180 naga-sone cho, Kita-ku, Sakai-city, Osaka

TEL

072-252-3021

Email

tokoro-a@kch.hosp.go.jp

Name of contact person

1st name
Middle name
Last name	Satomi Nakano

Organization

EP-CRSU Japane Co., Ltd.

Division name

Clinical Research Headquarters

Zip code

Address

4-1-1 Koraibashi, Chuo-ku, Osaka

TEL

06-6202-5375

Homepage URL

Email

prj-oicj-office@eps.co.jp

Institute

SHIONOGI & Co., Ltd

Institute

Department

Personal name

Organization

SHIONOGI & Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2017

Year

01

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2017

Year

01

Month

23

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

27

Day

Last follow-up date

2018

Year

01

Month

23

Day

Date of closure to data entry

2018

Year

03

Month

12

Day

Date trial data considered complete

2018

Year

03

Month

13

Day

Date analysis concluded

2018

Year

03

Month

30

Day

Other related information

NA

Registered date

2017

Year

01

Month

26

Day

Last modified on

2018

Year

06

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029742