UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013702 |
|---|---|
| Receipt number | R000015997 |
| Scientific Title | Efficacy of GMA in steroid naive patients with active ulcerative colitis. -a multicenter study - |
| Date of disclosure of the study information | 2014/04/13 |
| Last modified on | 2018/10/15 20:05:06 |
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Basic information
Public title
Efficacy of GMA in steroid naive patients with active ulcerative colitis. -a multicenter study -
Acronym
To evaluate the efficacy of GMA in steroid naive patients with active ulcerative colitis.
Scientific Title
Efficacy of GMA in steroid naive patients with active ulcerative colitis. -a multicenter study -
Scientific Title:Acronym
To evaluate the efficacy of GMA in steroid naive patients with active ulcerative colitis.
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of GMA in steroid naive patients with active ulcerative colitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Remission rate
Key secondary outcomes
1.Improvement of endoscopic index.
2.The incidence of adverse events.
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Steroid naive patients.
2. Patients refractory to high dose 5-ASA agents.
3. Antibiotics naive patients.
4. Patients with Mayo score 3 to 10.
Key exclusion criteria
1. Re-registered patients.
2. Patients whose granulocyte count below 2,000/mm3.
3. Patients with or suspected to have severe infection.
4. Patients with serious heart disease.
5. Patients with serious kidney disorder.
6. Patients with hypotension (mamimal blood pressure below 80mmHg).
7. Pregnant patients
8. Patients with serious dehydration, serious coagulation abnormality, or serious anemia (Hb below 8.0d/dL).
9. Patients with malignancy.
10. Patients who have artificial anus.
11. Patients who have undergone intestinal operation within 12 weeks.
12. Patients who have severe extraintestinal complications.
13. Patients who have received an initial dose or an increased dose of 5-ASA agents within 2 weeks before screening.
14. Patients who have received a dose of tacrolimus within 4 weeks before screening.
15. Patients who have received cytapheresis within 4 weeks before screening.
16. Patiens who have received an initial dose or an increased dose of immunomodulators within 8 weeks before screening.
17. Patients who are judged to be ineligible by an investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Higuchi |
Organization
Osaka Medical College Hospital
Division name
2nd Department of Internal Medicine
Zip code
Address
2-7, Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL
072-683-1221
ninaika@art.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Kakimoto |
Organization
Osaka Medical College Hospital
Division name
2nd Department of Internal Medicine
Zip code
Address
2-7, Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL
072-683-1221
Homepage URL
in2098@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College 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
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
| 2014 | Year | 04 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2014 | Year | 04 | Month | 13 | Day |
Last modified on
| 2018 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015997
