UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025864
Receipt No. R000029742
Scientific Title Prospective Observational Study on Opioid-induced Constipation in Patients with Cancer Pain in Japan
Date of disclosure of the study information 2017/01/26
Last modified on 2018/06/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
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
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

Public contact
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

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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 26 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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.