UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031891 |
|---|---|
| Receipt number | 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 | 2023/01/19 14:22:35 |
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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 | Obstetrics 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
Open -no one is 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
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
takaomi0027@gmail.com
Sponsor or person
Institute
Yokohama city university hospotal
Institute
Department
Personal name
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
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
None
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
100
Results
Nardimedine administered concurrently with opioid administration was significantly less worsening of JPAC-QOL compared to magnesium oxide administration.
Results date posted
| 2023 | Year | 01 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cancer patients requiring oral opioids
Participant flow
Pragmatic
Adverse events
The magnesium oxide group had higher nausea.
Outcome measures
Nardimedine administered concurrently with opioid administration was significantly less worsening of JPAC-QOL compared to magnesium oxide administration.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036408
