UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020900 |
|---|---|
| Receipt number | R000024112 |
| Scientific Title | An investigator initiative trial of STNM01 by an Endoscopic Submocal Injection to Investigate the Efficacy in Patients with Ulcerative Colitis |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2024/03/29 11:44:47 |
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Basic information
Public title
An investigator initiative trial of STNM01 by an Endoscopic Submocal Injection to Investigate the Efficacy in Patients with Ulcerative Colitis
Acronym
An investigator initiative trial to investigate the efficacy in patients with Ulcerative colitis
Scientific Title
An investigator initiative trial of STNM01 by an Endoscopic Submocal Injection to Investigate the Efficacy in Patients with Ulcerative Colitis
Scientific Title:Acronym
An investigator initiative trial to investigate the efficacy in patients with Ulcerative colitis
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of STNM01 by an Endoscopic Submocal Injection in Patients with Inflammatory bowel disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Endoscopic response
Key secondary outcomes
Endoscopic remission
Adverse effects and adverse drug reactions
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Study drug will be administered by an endoscope to active mucosal lesions. The patients will be received 250 nM of STNM01 on Day 1, Day 15 and Day 29. They will return to the study site for follow-up examination 2, 4 and 6 weeks after first administration.
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The subject is a patient with Ulcerative colitis or Crohns disease with active mucosal lesion.
2) The subject has been treated for more than 3 months before the screening tests by conventional drug generally used to treat Ulcerative colitis of Crohns disease. In the opinion of his primary doctor, the subject has experienced an insufficient response or resistance to the current conventional treatment. The subjects insufficient response or resistance to the current treatment is also confirmed by the principal investigator of this study, based on the screening tests including endoscopic examination, clinical examination and laboratory tests.
The subject experiencing an insufficient response or resistance can be assessed at the principal investigators discretion; however, use of more than one prescribed medication and insufficient therapeutic effect by the medication at present should be documented in the subjects medical record.
3) The subject has little difficulty with the introduction of an endoscope, e.g., he has little stenosis or, if any, the diameter of the narrowed lesion is 14 mm or more.
4) The subject signs and dates a written informed consent to participate in the study.
Key exclusion criteria
1) The subject has or has a history of serious cardiac, hematological or pulmonary disease, and is unsuitable.
2) The subject has a history of complete colon resection surgery.
3) The subject has a complication of Ulcerative colitis such as severe bleeding or intestinal adhesions to other organs, and is unsuitable.
4) The subject has a hepatic impairment or renal disorder, and is unsuitable.
5) The subject has or has a history of malignant tumor within the past 5 years.
6) The subject has or has a history of abdominal phthisis.
7) The subject has a complication of serious infection that requires hospitalization.
8) The subject should be excluded if he is currently treated with an anti-TNF- antibody and has one or more of the following conditions:
(1) The subject has a complication or history of tuberculosis.
(2) The subject has any of the following conditions other than tuberculosis.
9) The subject has a history of clinically serious allergic symptom.
10) The person has alcohol or drug dependency.
11) The subject is currently participating or plans to participate in another clinical study during the course of this study.
12) The subject has any psychiatric or neurological disorder, and is unsuitable.
13) For females, pregnancy or lactation.
14) Not willing and able to use a reliable and acceptable contraceptive method (Pearl Index < 1). The subjects or their sexual partners, respectively, must use at least one of these reliable methods from 6 weeks before until 3 weeks after the administration of the study medication.
15) The subject is considered by the investigator, for any other reason, to be unsuitable for participating in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yukinori |
| Middle name | |
| Last name | Sameshima |
Organization
Sameshima Hospital
Division name
internal medicine
Zip code
8920846
Address
9-8 Kajiya-cho, Kagoshima-city, Kagoshima 892-0846
TEL
099-224-2277
hsam@sameshima.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Sameshima |
Organization
Sameshima Hospital
Division name
internal medicine
Zip code
8920846
Address
9-8 Kajiya-cho, Kagoshima-city, Kagoshima 892-0846
TEL
099-224-2277
Homepage URL
hsam@sameshima.jp
Sponsor or person
Institute
Sameshima Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sameshima hospital
Address
9-8kajiya-cho Kagoshima city
Tel
992242277
hsam@sameshima.jp
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 | 02 | Month | 08 | 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
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
| 2015 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024112
