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UMIN-CTR Clinical Trial |
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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 |
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 | |
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Condition | ||||||||||||||||||||||||||||||||||||||
Condition | Cancer patients prescribing opioids | |||||||||||||||||||||||||||||||||||||
Classification by specialty |
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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 |
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Interventions/Control_1 | Magnesium oxide | |
Interventions/Control_2 | Naldemedine | |
Interventions/Control_3 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | No longer recruiting | ||||||
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Last modified on |
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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 | |
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Research case data | |
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