UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of THN-01 in patients undergoing two-staged gastrointestinal surgery (a confirmatory study) -a randomized, double-blind, parallel-group comparative, multicenter, placebo-controlled study-
Title of the study (Brief title)	A clinical study of THN-01 in patients undergoing two-staged gastrointestinal surgery (a confirmatory study)
Region	Japan

Condition
Condition	Patients who need the entire colectomy and are planned to receive the first stage surgery (ileostomy) of two-staged surgery
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm adhesion-reducing effects by the total number of adhesions formed in the abdominal cavity at the second stage surgery and safety of THN-01 in the patients receiving two-staged gastrointestinal surgery and being administered investigational device (THN-01) or control device (saline) at the end of the first stage surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The total number of adhesions formed in the abdominal cavity
Key secondary outcomes	(1)Presence/absence of adhesion in the entire abdominal cavity (2)Scores for extent and severity of adhesion in the entire abdominal cavity (3)The number of adhesions formed in the area including small intestine (4)Presence/absence of adhesion in the area including small intestine (5)Scores for extent and severity of adhesion in the area including small intestine (6)The number of adhesions dissected

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Using THN-01 at the first stage surgery
Interventions/Control_2	Using placebo at the first stage surgery
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) Patients who need the entire colectomy due to such as ulcerative colitis or familial polyposis coli (2) Patients who are planned to receive the first stage surgery (ileostomy) of two-staged surgery (3) Patients aged 20 years or older at the time of informed consent (4) Patients who can provide written informed consent
Key exclusion criteria	(1) Patients who have a history of intraperitoneal surgery except the surgeries for specific organs such as appendicectomy (2) Patients with peritonitis or a history of it (3) Patients with endometriosis or a history of it (4) Patients with bowel cancer of stage >=II (5) Patients with digestive tract perforation (6) Patients who are pregnant, lactating, or plannig to be pregnant (7) Patients who have been treated with an unapproved medicine or medical device within 16 weeks before the day of informed consent (8) Others who have been determined ineligible by principal investigator or sub-investigator
Target sample size	48

Research contact person
Name of lead principal investigator	Masato Kusunoki
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	2-174 Edobashi, Tsu, Mie, Japan
TEL	059-232-1111
Email	surgery2@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Yoshihiro Kume
Organization	Otsuka Pharmaceutical Factory, Inc.
Division name	Clinical Development Department
Address	1-1 Kanda-Ogawamachi, Chiyoda-ku Tokyo
TEL	03-5280-2721
Homepage URL
Email	Kume.Yoshihiro@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Factory, Inc.
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	三重大学病院(三重県)、兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 08 Day
Anticipated trial start date	2014 Year 01 Month 28 Day
Last follow-up date
Date of closure to data entry	2016 Year 01 Month 25 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	A total of 42 subjects, out of which 22 were in the test device group (THN group) and 20 were in the control group (PLC group), were used for the efficacy analysis. As a result, the total number of adhesions formed in the abdominal cavity, which was the primary outcome, were not significantly different between two groups (median, 11.5 vs 11.0; p = 0.779), which shows the adhesion-reducing effects of THN-01 were not confirmed. All secondary outcomes of THN group were similar to those of PLC group. A total of 47 subjects who received the investigational devices, out of which 24 were in the THN group and 23 were in the PLC group, were used for the safety analysis. The analysis shows that the subjects experienced adverse events including gastrointestinal stoma complications, dehydration, electrolyte imbalance, hepatic function abnormal, and failure to anastomose. These adverse events are known to occur after the first-stage surgery (ileostomy) of two-staged surgery of ulcerative colitis. The incidence and episode number of adverse events were 87.5% (21 of 24 study subjects) and 82 events in the THN group and 91.3% (21of 23 study subjects) and 56 events in the PLC group. No device-related adverse event occurred in either of the groups. Vital signs and laboratory values changed and distributed as shown in the typical patient after the first-stage surgery. Those changes and distribution shown in the THN group were not different from those in the PLC group. In conclusion, no safety issues were identified for THN-01.
Other related information

Management information
Registered date	2014 Year 02 Month 04 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015249