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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013070
Receipt No. R000015249
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-
Date of disclosure of the study information 2014/02/18
Last modified on 2017/04/17

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 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

Progress
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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