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 |
An investigator initiative trial of STNM01 by an Endoscopic Submocal Injection to Investigate the Efficacy in Patients with Ulcerative Colitis
An investigator initiative trial to investigate the efficacy in patients with Ulcerative colitis
An investigator initiative trial of STNM01 by an Endoscopic Submocal Injection to Investigate the Efficacy in Patients with Ulcerative Colitis
An investigator initiative trial to investigate the efficacy in patients with Ulcerative colitis
Japan |
Inflammatory bowel disease
Gastroenterology |
Others
NO
To evaluate the efficacy of STNM01 by an Endoscopic Submocal Injection in Patients with Inflammatory bowel disease
Safety,Efficacy
Not applicable
Endoscopic response
Endoscopic remission
Adverse effects and adverse drug reactions
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
16 | years-old | <= |
75 | years-old | > |
Male and Female
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.
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.
10
1st name | Yukinori |
Middle name | |
Last name | Sameshima |
Sameshima Hospital
internal medicine
8920846
9-8 Kajiya-cho, Kagoshima-city, Kagoshima 892-0846
099-224-2277
hsam@sameshima.jp
1st name | Yukinori |
Middle name | |
Last name | Sameshima |
Sameshima Hospital
internal medicine
8920846
9-8 Kajiya-cho, Kagoshima-city, Kagoshima 892-0846
099-224-2277
hsam@sameshima.jp
Sameshima Hospital
None
Self funding
Sameshima hospital
9-8kajiya-cho Kagoshima city
992242277
hsam@sameshima.jp
NO
2016 | Year | 02 | Month | 08 | Day |
Unpublished
Completed
2015 | Year | 12 | Month | 28 | Day |
2016 | Year | 01 | Month | 20 | Day |
2016 | Year | 02 | Month | 08 | Day |
2016 | Year | 04 | Month | 30 | Day |
2016 | Year | 02 | Month | 05 | Day |
2024 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024112