UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical research of postoperative adhesion in patients registered to previous clinical studies of THN-01 -multicenter, retrospective research-
Title of the study (Brief title)	A clinical research of postoperative adhesion in patients registered to previous clinical studies of THN-01
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Out of the patients registered to previous two clinical studies of THN-01, the patients included in the full analysis set (FAS) used for efficacy analysis are selected for this study. The aims of this study are to estimate the factors which can affect postoperative adhesions, and to confirm and evaluate the possible factors affecting clinical outcomes, following to examination of disease conditions of ulcerative colitis, preoperative treatments, and other information.
Basic objectives2	Others
Basic objectives -Others	Follow-up of the clinical study
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The possible factors affecting postoperative adhesion and clinical outcomes, such as disease conditions of ulcerative colitis and preoperative medical treatments
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who can provide written informed consent
Key exclusion criteria	-
Target sample size	64

Research contact person
Name of lead principal investigator	Hisanori Saegusa
Organization	Otsuka Pharmaceutical Factory, Inc.
Division name	Clinical Development Department, Research and Development Center
Address	5F Nikko Kanda Building, 1-1 Ogawa-machi, Kanda, Chiyoda-ku, Tokyo
TEL	03-5280-2721
Email	saegusah@otsuka.jp

Public contact
Name of contact person	Yoshihiro Kume
Organization	Otsuka Pharmaceutical Factory, Inc.
Division name	Clinical Development Department, Research and Development Center
Address	5F Nikko Kanda Building, 1-1 Ogawa-machi, Kanda, 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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 07 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2016 Year 11 Month 30 Day
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	We evaluated the clinical condition and preoperative medical treatment of the patients registered in the clinical studies of THN-01 and evaluated for efficacy. As a result, the medical history of the specific drugs could affect postoperative adhesion and the results of clinical studies.
Other related information	Follow-up of the clinical study

Management information
Registered date	2016 Year 08 Month 16 Day
Last modified on	2017 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027229