UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000300 |
|---|---|
| Receipt number | 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 09:31:07 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000363
