UMIN-CTR Clinical Trial

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

Patients with ulcerative colitis in active phase

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Reduction degree of UC-DAI

Key secondary outcomes

Reduction degree of score of each UC-DAI item.
Remission rate.
Efficacy rate.

Study type

Interventional

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

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

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

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

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

Institute

Zeria Pharmaceutical Co.,LTD.

Institute

Department

Personal name

Organization

Zeria Pharmaceutical Co.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2005

Year

11

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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=R000000361