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

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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


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 Resarch

Zip code


Address

10-11,Nihonbashi,Kobuna-cho,Chuo-ku,Tokyo,103-8351,Japan

TEL


Homepage URL


Email

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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000362


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name