UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan
Title of the study (Brief title)	Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan
Region	Japan

Condition
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

Objectives
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

Assessment
Primary outcomes	Morbidity of OIC based on ROME IV diagnostic criteria
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Akihiro Tokoro
Organization	National Hospital Organization Kinki-chuo Chest Medical Center
Division name	Department of psychosomatic medicine/ Palliative care team
Address	1180 naga-sone cho, Kita-ku, Sakai-city, Osaka
TEL	072-252-3021
Email	tokoro-a@kch.hosp.go.jp

Public contact
Name of contact person	Satomi Nakano
Organization	EP-CRSU Japane Co., Ltd.
Division name	Clinical Research Headquarters
Address	4-1-1 Koraibashi, Chuo-ku, Osaka
TEL	06-6202-5375
Homepage URL
Email	prj-oicj-office@eps.co.jp

Sponsor
Institute	SHIONOGI & Co., Ltd
Institute
Department

Funding Source
Organization	SHIONOGI & Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 01 Month 26 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	NA

Management information
Registered date	2017 Year 01 Month 26 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029742