UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023644
Receipt No. R000027229
Scientific Title A clinical research of postoperative adhesion in patients registered to previous clinical studies of THN-01 -multicenter, retrospective research-
Date of disclosure of the study information 2016/09/01
Last modified on 2017/04/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical research of postoperative adhesion in patients registered to previous clinical studies of THN-01
-multicenter, retrospective research-
Acronym A clinical research of postoperative adhesion in patients registered to previous clinical studies of THN-01
Scientific Title A clinical research of postoperative adhesion in patients registered to previous clinical studies of THN-01
-multicenter, retrospective research-
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisanori Saegusa
Organization Otsuka Pharmaceutical Factory, Inc.
Division name Clinical Development Department, Research and Development Center
Zip code
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
1st name
Middle name
Last name Yoshihiro Kume
Organization Otsuka Pharmaceutical Factory, Inc.
Division name Clinical Development Department, Research and Development Center
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
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.
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
2016 Year 06 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.