UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022710 |
|---|---|
| Receipt number | R000026162 |
| Scientific Title | A Randomized, Multicenter, Repeat-Dose Study of Intravenous Acetaminophen With Epidural Analgesia for the Treatment of Pain After Gastrectomy |
| Date of disclosure of the study information | 2016/06/12 |
| Last modified on | 2016/12/12 21:43:06 |
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Basic information
Public title
A Randomized, Multicenter, Repeat-Dose Study of
Intravenous Acetaminophen With Epidural Analgesia for
the Treatment of Pain After Gastrectomy
Acronym
A Randomized Study of Intravenous Acetaminophen for
the Pain After Gastrecotmy
Scientific Title
A Randomized, Multicenter, Repeat-Dose Study of
Intravenous Acetaminophen With Epidural Analgesia for
the Treatment of Pain After Gastrectomy
Scientific Title:Acronym
A Randomized Study of Intravenous Acetaminophen for
the Pain After Gastrecotmy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the analgesic efficacy of repeated doses of intravenous acetaminophen with epidural analgesia compared with epidural analgesia alone over 48 hours in subjects with moderate to severe pain after distal gastrecomty for gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of requiring rescue analgesics of edidural analgesia after surgery for 48 hours
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravenous acetaminophen(1000mg) for every 6 hours
for 72 postoperative hours in conjunction with epidural
analgesia after distal gastrectomy
Interventions/Control_2
epidural analgesia as standard treatment after distal
gastrectomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven adenocarcinoma of the stomach
2) Surgically resectable tumor (cT1-4a, N0-3b, M0) by
distal gastrectomy
3) Age 20 > years
4) ECOG performance status 0 or 1.
5) No prior treatment of chemotherapy or radiation
therapy against any other malignancies.
6) Cases with adequately maintained organ functions and
fullfilling the following conditions within 8 weeks
before registration.
WBC>3000
Plt>100000
AST<100
ALT<100
Total bilrbin<2.0mg/dL
Serum creatinine<1.5mg/dL
7) Written informed consent
Key exclusion criteria
1) Synchronous or metachronous (within 5 years)
malignancies other than carcinoma in situ.
2) Inappropriate for epidural anesthesia
3) Infectious disease with a systemic therapy indicated.
4) Body temperature of 38C or more.
5) History of hypersensitivity of acetaminophen
6) History of hypersensitivity of aspirin-induced asthma
7) Severe mental disease.
8) Continuous systemic steroid therapy.
9) Unstable angina pectoris or history of myocardial
infarction within 6 months.
10) Uncontrollable hypertension.
11) Uncontrollable diabetes mellitus
12) Severe respiratory disease requiring continuous
oxygen therapy.
13) Women during pregnancy or breast feeding.
14) Judged inappropriate by the investigators
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachio Fushida |
Organization
Digestive Disease Support Organization (DDSO)
Division name
Gastroenterologic surgery
Zip code
Address
35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
TEL
076-265-2000
junkino0416@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kinoshita |
Organization
Digestive Disease Support Organization (DDSO)
Division name
Gastroenterologic surgery
Zip code
Address
35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
TEL
076-265-2000
Homepage URL
junkino0416@gmail.com
Sponsor or person
Institute
Digestive Disease Support Organization (DDSO)
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 12 | Day |
Last modified on
| 2016 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026162
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
