UMIN-CTR Clinical Trial

Basic information
Public title	Superiority comparative test of conventional treatment vs naldemedine for prevention of opioid-induced constipation in cancer patients: Investigator initiated, single center, 2 arm, open label, randomized controlled trials
Acronym	Superiority comparative test of conventional treatment vs naldemedine for prevention of opioid-induced constipation in cancer patients: Investigator initiated, single center, 2 arm, open label, randomized controlled trials
Scientific Title	Superiority comparative test of conventional treatment vs naldemedine for prevention of opioid-induced constipation in cancer patients: Investigator initiated, single center, 2 arm, open label, randomized controlled trials
Scientific Title:Acronym	Superiority comparative test of conventional treatment vs naldemedine for prevention of opioid-induced constipation in cancer patients: Investigator initiated, single center, 2 arm, open label, randomized controlled trials
Region	Japan

Condition
Condition	Cancer patients prescribing opioids
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Cardiology Pneumology Endocrinology and Metabolism Hematology and clinical oncology Nephrology Neurology Clinical immunology Psychosomatic Internal Medicine Infectious disease Geriatrics Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Dermatology Oto-rhino-laryngology Orthopedics Urology Radiology Anesthesiology Oral surgery Neurosurgery Cardiovascular surgery Plastic surgery Emergency medicine Intensive care medicine Rehabilitation medicine Dental medicine Nursing Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will compare the effect against quality of life (QOL) between conventional treatment (magnesium oxide) and naldemedine on the prevention of opioid-induced constipation with cancer patients .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	PAC-QOL overall score difference after 2 weeks of treatment start from Baseline.
Key secondary outcomes	1,PAC-SYM overall score difference after 2 weeks of treatment start from Baseline. 2,CSS overall score difference after 2 weeks of treatment start from Baseline. 3,Difference in the presence or absence of constipation by Rome IV (all observation period) after 2 weeks of treatment start from Baseline. 4,Bristol scale overall score difference after 2 weeks of treatment start from Baseline. 5,SMBs overall score difference after 2 weeks of treatment start from Baseline. 6,PAC-QOL overall score difference after 12 weeks of treatment start from Baseline. 7,PAC-SYM overall score difference after 12 weeks of treatment start from Baseline. 8,CSS overall score difference after 12 weeks of treatment start from Baseline. 9,Difference in the presence or absence of constipation by Rome IV (all observation period) after 12 weeks of treatment start from Baseline. 10,Bristol scale overall score difference after 12 weeks of treatment start from Baseline. 11,SMBs overall score difference after 12 weeks of treatment start from Baseline. 12,Oral compliance rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Magnesium oxide
Interventions/Control_2	Naldemedine
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1,Patients aged 20 to 85 years of age at the time of acquisition. 2,Gender, hospitalization / outpatient: no question 3,Patients who are not undergoing opioid analgesic treatment 4,Patients scheduled to use opioids due to cancer pain 5,Patients who can take oral medicine, meals and drinks 6,Patient who can be evaluated by patient diary (Surrogate record to patient's diary is permitted only when patient's own evaluation is possible) 7,Patients who are expected to have stable cancer pathology during the observation period 8,Patient who got written consent from participants to participate in this research, observe observance matter participating in this research, undergo examination prescribed in this research plan, and can declare symptoms etc.
Key exclusion criteria	1,Patients who are contraindicated in the package inserts of magnesium oxide and naldemedine and patients who have a history of hypersensitivity to the components of this drug. 2,Serious structural abnormalities of the digestive tract (eg mechanical ileus), diseases affecting intestinal transport (eg paralytic ileus, peritoneal dissemination affecting gastrointestinal function, peritoneal cancer, uncontrolled thyroid function decline (IBS), inflammatory bowel disease (eg ulcerative colitis, Crohn's disease), active diverticular disease, pelvic disorders causing constipation (uterine prolapse, rectal prolapse, defecation A patient with uterine fibroids affecting). Also, even if these diseases are cured at present, patients judged by doctors to affect digestive tract function 3,Patient who is breastfeeding or may be pregnant. 4,Patients who underwent surgery that affects gastrointestinal function, treatment (eg nerve block) or radiotherapy affecting gastrointestinal function within 28 days from the date of registration or patients scheduled to be performed during the observation period
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Takaomi Middle name Last name Kessoku
Organization	Yokohama city university hospotal
Division name	Palliative care
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa-ku
TEL	0457872640
Email	takaomi0027@gmail.com

Public contact
Name of contact person	1st name Takaomi Middle name Last name Kessoku
Organization	Yokohama city university hospotal
Division name	Palliative care
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
TEL	0457872640
Homepage URL
Email	takaomi0027@gmail.com

Sponsor
Institute	Yokohama city university hospotal
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Yokohama city university hospotal
Address	3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
Tel	0457872640
Email	takaomi0027@gmail.com

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	2018 Year 03 Month 25 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 11 Month 26 Day
Date of IRB	2018 Year 03 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 26 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 25 Day
Last modified on	2020 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036408

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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