UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized, Multicenter, Repeat-Dose Study of Intravenous Acetaminophen With Epidural Analgesia for the Treatment of Pain After Gastrectomy
Title of the study (Brief title)	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	Sachio Fushida
Organization	Digestive Disease Support Organization (DDSO)
Division name	Gastroenterologic surgery
Address	35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
TEL	076-265-2000
Email	junkino0416@gmail.com

Public contact
Name of contact person	Jun Kinoshita
Organization	Digestive Disease Support Organization (DDSO)
Division name	Gastroenterologic surgery
Address	35-1, Yonemaru-machi, Kanazawa, Ishikawa 921-8004, Japan
TEL	076-265-2000
Homepage URL
Email	junkino0416@gmail.com

Sponsor
Institute	Digestive Disease Support Organization (DDSO)
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026162