![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000288 |
Receipt No. | R000000361 |
Scientific Title | Z-206 Phase III Clinical Trial - Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - |
Date of disclosure of the study information | 2005/11/21 |
Last modified on | 2007/11/21 |
Basic information | ||
Public title | Z-206 Phase III Clinical Trial
- Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - |
|
Acronym | Z-206 Phase III Clinical Trial
- Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - |
|
Scientific Title | Z-206 Phase III Clinical Trial
- Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - |
|
Scientific Title:Acronym | Z-206 Phase III Clinical Trial
- Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - |
|
Region |
|
Condition | ||
Condition | Patients with ulcerative colitis in active phase | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The objective of this clinical trial is to verify the superiority that Z-206 3.6 g/day is superior to mesalazine tablet 2.25 g/day and the non-inferiority that Z-206 2.4 g/day is not inferior to mesalazine tablet 2.25 g/day. In the study, the patients with ulcerative colitis in active phase are enrolled as subject, and the remission induction activity is examined using the reduction rate of score of Ulcerative Colitis-Disease Activity Index (UC-DAI) 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 | Reduction degree of UC-DAI |
Key secondary outcomes | Reduction degree of score of each UC-DAI item.
Remission rate. Efficacy rate. |
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 | 4 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | Z-206 2.4g/day dose group: Two Z-206 400mg tablets, 1 tablet of Z-206 placebo tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks. |
|
Interventions/Control_2 | Z-206 3.6g/day dose group: Three tablets of Z-206 400mg tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks. |
|
Interventions/Control_3 | Mesalazine group: Three tablets of Pentasa 250 mg tablet and 3 tablets of Z-206 placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks. |
|
Interventions/Control_4 | Placebo group: Three tablets of Z-206 placebo tablet and 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks. |
|
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1)Patients with ulcerative colitis at remission phase who are defined to show UC-DAI score of 3 or higher but 8 or less, and bloody stool score of 1 or higher.
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 with serious according to diagnostic criteria of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course are to be excluded.
2)Patients who take mesalazine oral formulation with a dosage of 2.25 g/day within 14 days before initiation of the study drug, or patients with who take salazosulfapyrdine oral formulation with a dosage of 4.5 g/day within 14 days before initiation of the study drug 3) Patients who take mesalazine enemas or salazosulfapyrdine suppository within 14 days before initiation 4) 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. 5) Patients who are administered immune-suppressing drug before start of administration of clinical study drug within 90 day. 6) Patients who are treated by blood cell apheresis within 14 days before start of administration of clinical study drug. 7) Patients with history of drug hypersensitivity to mesalazine formulation and drugs of salicylic acid groups. 8) Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease.) 9) Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia or lung disease. 10) Patients with malignant tumor as complication.11) Pregnants, females who suckles, or females who wish to become pregnant. 12) Patients who are administered some kinds of clinical study drug within 6 months before obtaining informed consent. 13) Others, patients who are judged to be inadequate to participate in this trial by the principal investigator or co-investigator. |
|||
Target sample size | 210 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
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 | 03-3353-1211 | ||||||
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Zeria Pharmaceutical Co.,LTD. | ||||||
Division name | Clinical Research | ||||||
Zip code | |||||||
Address | 10-11,Nihonbashi,Kobuna-cho,Chuo-ku,Tokyo,103-8351,Japan | ||||||
TEL | |||||||
Homepage URL | |||||||
kaihatu@zeria.co.jp |
Sponsor | |
Institute | Zeria Pharmaceutical Co.,LTD. |
Institute | |
Department |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000361 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |