UMIN-CTR Clinical Trial

Public title

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-

Acronym

A clinical study of THN-01 in patients undergoing two-staged gastrointestinal surgery (a confirmatory study)

Scientific Title

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-

Scientific Title:Acronym

A clinical study of THN-01 in patients undergoing two-staged gastrointestinal surgery (a confirmatory study)

Region

Japan

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

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Masato Kusunoki

Organization

Mie University Graduate School of Medicine

Division name

Department of Gastrointestinal and Pediatric Surgery

Zip code

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

059-232-1111

Email

surgery2@clin.medic.mie-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoshihiro Kume

Organization

Otsuka Pharmaceutical Factory, Inc.

Division name

Clinical Development Department

Zip code

Address

1-1 Kanda-Ogawamachi, Chiyoda-ku Tokyo

TEL

03-5280-2721

Homepage URL

Email

Kume.Yoshihiro@otsuka.jp

Institute

Otsuka Pharmaceutical Factory, Inc.

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Factory, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

三重大学病院(三重県)、兵庫医科大学病院（兵庫県）

Date of disclosure of the study information

2014

Year

02

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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.

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

10

Month

08

Day

Date of IRB

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

Other related information

Registered date

2014

Year

02

Month

04

Day

Last modified on

2017

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015249