UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023644 |
|---|---|
| Receipt number | 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 11:25:05 |
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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
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
Kume.Yoshihiro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Factory, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.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 |
