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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031891
Receipt No. R000036408
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
Date of disclosure of the study information 2018/03/25
Last modified on 2020/10/23

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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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