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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000300
Receipt No. R000000363
Scientific Title Z-206 Phase III Clinical Trial - Investigation on the remission-inducing effect in patients with Crohn's disease in active phase -
Date of disclosure of the study information 2005/12/22
Last modified on 2006/08/29

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Basic information
Public title Z-206 Phase III Clinical Trial
- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase -
Acronym Z-206 Phase III Clinical Trial
- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase -
Scientific Title Z-206 Phase III Clinical Trial
- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase -
Scientific Title:Acronym Z-206 Phase III Clinical Trial
- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase -
Region
Japan

Condition
Condition Patients with Crohn's disease in active phase
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this trial is to examine the effect and safety of Z-206
3.6 g/day in patients with Crohn's disease in active phase using
mesalazine tablet as control drug.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Remission induction rate
Degree of decrease in CDAI
QOL (IBDQ)
Key secondary outcomes

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Interventions/Control_2 Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Interventions/Control_3 Placebo group:Three tablets of Z-206 placebo tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
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 whose Crohn's Disease Activity Index (CDAI) is not less
than 150 but less than 250 are defined to be in active phase.
2)Patients whose lesion is mainly observed in the end of ileum or
lower part.
3) Outpatients with age of 16 or older and 64 or younger at the time of
obtaining informed consents (however, no restriction on sex).
4) Patients who understand the substances of this clinical trial and can
give consent to participate in this clinical trial in writing. In a case of
a patient with age below 20 at the time of obtaining informed
consent, a patient for whom consent can be obtained from his or her
custodian.
Key exclusion criteria 1)Patients to whom oral formulation of mesalazine of a dose
exceeding 3 g/day was administered or oral formulation of
salazosulfapyridine of a dose exceeding 6 g/day was administered
within 7 days of the start of administration of this trial drug.
2)Patients to whom mesalazine enema or salazosulfapyridine
suppository was given within 7 days of the start of administration of
this clinical study drug.
3)Patients who took adrenal cortex hormone within 14 days before start of administration of clinical
study drug.
4)Patients who were given metronidazole or ciprofloxacin within 14
days before start of administration of clinical study drug.
5)Patients who were administered immune-suppressing drugs within
90 days before start of administration of clinical study drug.
6)Patients who were administered infliximab (anti-human TNF-alpha
monoclonal antibody) within 90 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 history of enterectomy for Crohn's disease.
9)Patients with active anal lesion (Patients with anal stenosis that
affect number of defecation, or patients with anal fistula
accompanied by fever)
10)Patients treated by total parenteral nutrition method.
11)Patients with liver disease or kidney disease (Each clinician will
judge the presence or absence of liver disease or kidney disease).
12)Patients with serious cardiovascular disease, hemodyscrasia or lung
disease, or patients with history of serious cardiovascular disease,
hemodyscrasia, lung disease.
13)Patients with malignant tumors
14)Patients who are pregnant, breast-feeding or desire to become
pregnant during this trial period
15)Patients who were administered some kinds of clinical study drug
within 6 months before obtaining informed consent.
16)Patients whom principle investigator or co-investigator judged unfit
to participate in this trial.
Target sample size 60

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 12 Month 22 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 Terminated
Date of protocol fixation
2005 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2006 Year 03 Month 01 Day
Date of closure to data entry
2006 Year 03 Month 01 Day
Date trial data considered complete
2006 Year 03 Month 01 Day
Date analysis concluded
2006 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 12 Month 22 Day
Last modified on
2006 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000363

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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