UMIN-CTR Clinical Trial

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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