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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

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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
Japan

Condition
Condition Patients with ulcerative colitis in active 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 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
Medicine
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
16 years-old <=
Age-upper limit
64 years-old >
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
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 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Zeria Pharmaceutical Co.,LTD.
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
Email 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
Email

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
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


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