UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000289 |
|---|---|
| Receipt number | R000000362 |
| Scientific Title | Z-206 Phase III Clinical Trial - Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase - |
| Date of disclosure of the study information | 2005/11/21 |
| Last modified on | 2007/11/21 10:46:39 |
* 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
Z-206 Phase III Clinical Trial
- Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase -
Acronym
Z-206 Phase III Clinical Trial
- Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase -
Scientific Title
Z-206 Phase III Clinical Trial
- Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase -
Scientific Title:Acronym
Z-206 Phase III Clinical Trial
- Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase -
Region
| Japan |
Condition
Condition
Patients with ulcerative colitis in remission phase.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this clinical trial is to verify the non-inferiority assumption that Z-206 2.4 g/day is not inferior to mesalazine tablet 2.25 g/day by examining the incidence of bloody stool as primary evaluation item.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Non-incidence of bloody stool
Key secondary outcomes
Period of non-emergence of bloody stool.
Non-recurrence rates.
Period of non-recurrence of bloody stool, and change of UC-DAI.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Z-206 group : Two Z-206 400 mg tablets, 3 tablets of Pentasa placebo tablet per time (total 5 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Interventions/Control_2
Mesalazine group: Three tablets of Pentasa 250 mg tablet and 2 tablets of Z-206 placebo tablet per time (total 5 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
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
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with ulcerative colitis in remission phase who are defined to show Ulcerative Colitis-Disease Activity Index (UC-DAI) score of not less than 2 and bloody stool score of 0.
2) Subjects whose age is 16 years or older but less than 65 years old at the time of obtaining informed consent (no restriction for sex)
3) Patients who can understand the contents of this clinical trial, and from whom informed consent to participate in this trial is obtained in written form. In a case of patients under age (less than 20 years old) atthe acquisition time of the informed consent, a consent form can be obtained a representative of the patients.
Key exclusion criteria
1)Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal problem, injectable solution) within 14 days before start of administration of clinical study drug.
2)Patients who are administered immune-suppressing drug before start of administration of clinical study drug within 90 day.
3)Patients who are treated by blood cell apheresis within 14 days before start of administration of clinical study drug.
4)Patients with history of drug hypersensitivity to mesalazine formulation and drugs of salicylic acid groups.
5)Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease.)
6)Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia or lung disease.
7)Patients with malignant tumor as complication.
8)Pregnants, females who suckles, or females who wish to become pregnant.
9)Patients who are administered some kinds of clinical study drug within 6 months before obtaining informed consent. The clinical study drug administered in
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Hibi |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinano-Machi,Shinjuku-ku,Tokyo 160-8582,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zeria Pharmaceutical Co.,LTD. |
Organization
Zeria Pharmaceutical Co.,LTD.
Division name
Clinical Resarch
Zip code
Address
10-11,Nihonbashi,Kobuna-cho,Chuo-ku,Tokyo,103-8351,Japan
TEL
Homepage URL
kaihatu@zeria.co.jp
Sponsor or person
Institute
Zeria Pharmaceutical Co.,LTD.
Institute
Department
Personal name
Funding Source
Organization
Zeria Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2005 | Year | 11 | Month | 21 | 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
| 2005 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 11 | Month | 21 | Day |
Last modified on
| 2007 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000362
