UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004348 |
|---|---|
| Receipt number | R000005202 |
| Scientific Title | A multi-institutional study evaluating the effects of laxatives and antiemetics for prevention of opioid-induced adverse events -J-RIGID study- |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2012/01/12 11:33:32 |
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Basic information
Public title
A multi-institutional study evaluating the effects of laxatives and antiemetics for prevention of opioid-induced adverse events -J-RIGID study-
Acronym
J-RIGID study
Scientific Title
A multi-institutional study evaluating the effects of laxatives and antiemetics for prevention of opioid-induced adverse events -J-RIGID study-
Scientific Title:Acronym
J-RIGID study
Region
| Japan |
Condition
Condition
Cancer pain
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of premedication for prophylaxis of opioid-induced gastric dysfunction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of opioid-induced constipation, nausea and vomiting
Key secondary outcomes
Prevalence of premedication, Choice of laxatives and antiemetics
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cancer patients to whom oral formulation of strong opioid analgesic was newly prescribed
Key exclusion criteria
*Patients who received radiotherapy or chemotherapy during 10 days before start of ingestion of opioid analgesics or during study period
*Patients who received surgical operation during 7 days before start of ingestion of opioid analgesics or during study period
*Patients who took antiemetics or laxatives due to other reasons than prevention of opioid-induced gastrointestinal dysfunction
*Patients who had diarrhea or constipation before ingestion of opioid analgesics
*Patients who had nausea or vomiting due to organic dysfunction including brain tumor
*Patients whose performance status was 3 or 4
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Itoh |
Organization
Gifu University Hospital
Division name
Pharmacy
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-7080
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Itoh |
Organization
Gifu University Hospital
Division name
Pharmacy
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-7080
Homepage URL
yositou@gifu-u.ac.jp
Sponsor or person
Institute
Department of Pharmacy, Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
岐阜大学病院（岐阜）、岐阜市民病院（岐阜）、大垣市民病院（岐阜）、高山赤十字病院（岐阜）、岐阜県総合医療センター（岐阜）、長良医療センター（岐阜）、岐阜社会保険病院（岐阜）、松浪総合病院（岐阜）、羽島市民病院（岐阜）、坂下病院（岐阜）、九州大学病院（福岡）、九州中央病院（福岡）、九州厚生年金病院（福岡）、産業医科大学病院（福岡）、九州がんセンター（福岡）、浜の町病院（福岡）、福岡大学病院（福岡）、福岡徳洲会病院（福岡）、岡山大学病院（岡山）、倉敷中央病院（岡山）、岡山医療センター（岡山）、川崎医科大学病院（岡山）、倉敷成人病センター（岡山）、津山中央病院（岡山）、水島協同病院（岡山）、玉島中央病院（岡山）、岡山赤十字病院（岡山）、岡山済生会病院（岡山）、愛媛大学病院（愛媛）、松山赤十字病院（愛媛）、四国がんセンター（愛媛）、宇和島社会保険病院（愛媛）、宇和島病院（愛媛）、住友別子病院（愛媛）、松山市民病院（愛媛）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://journals.lww.com/clinicalpain/toc/publishahead
Number of participants that the trial has enrolled
Results
A total of 720 cancer patients receiving strong opioid analgesics from 35 institutions were enrolled, among whom 619 subjects were eligible. Prophylactic laxatives were medicated in 456 patients (74%), while antiemetics (mostly dopamine D2 blockers) were prescribed for prevention of nausea and vomiting in 435 subjects (70%). The incidence of constipation was significantly lower in patients receiving laxatives than in those without prophylactic medication (34% versus 55%, odds ratio [OR] 0.43, 95% confidence intervals [CI] 0.30-0.62, P<0.001), whereas nausea and vomiting occurred regardless of prophylactic treatment. Among laxatives, magnesium oxide (>=1,000 mg/day) was the only agent reducing the risk of constipation. Meta-analysis of OR determined in 14 institutions reporting >=16 patients indicated that overall OR for constipation was 0.47 (95% CI 0.23-0.96, P=0.04) in favor of prophylactic treatment, whereas administration of antiemetics was not a significant risk reducing the incidence of nausea and vomiting.
Therefore, it is evident that prophylactic laxatives including magnesium oxide (>=1,000 mg/day) reduces the incidence of constipation in patients receiving strong opioid analgesics. However, no evidence for prophylactic effect of antiemetics (dopamine D2 blocker) against opioid-induced nausea and vomiting was obtained. [Clinical Journal of Pain, in press]
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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Case-control study examining the relationship between prevalence of premedication and the incidence of opioid-induced gastrointestinal side effects
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2012 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005202
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