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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010906
Receipt No. R000012720
Scientific Title The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission.
Date of disclosure of the study information 2013/06/10
Last modified on 2015/03/28

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Basic information
Public title The exploratory randomized controlled trial by high-dose Asacol
treatment to patients with ulcerative colitis aiming to maintain
remission.
Acronym Asacol4.8 maintenance
Scientific Title The exploratory randomized controlled trial by high-dose Asacol
treatment to patients with ulcerative colitis aiming to maintain
remission.
Scientific Title:Acronym Asacol4.8 maintenance
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether the efficacy to maintain remission to the patients with ulcerative colitis is prolonged by high-dose Asacol treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Clinical response rate at week 24 by UCDAI score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A 24-week administration of 4.8g/day of Asacol
Interventions/Control_2 A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with ulcerative clolitis
2) Patients whose UCDAI score between 3 and 6 points (bloody stool score is more than 1 point)
3) Patients who are taking 3.6g of Asacol or 4.0g of Pentasa daily.
4) Patients who are over 15 and under 70 years of age.
Key exclusion criteria 1) Patients who took mesalazine enema or salazopyrine suppository in 2 weeks before the day of the registration for this study
2) Patients who took steroid fomula in 1 month before that day
3) Patients who started to take immunomodulators or to escalate the dose of the medicine before that day. In addition, the patients who took the drug more than 90 days without dose-escalation are not excluded.
4) Patients who started to take anti-TNFa therapy before that day. In addition, the patients who took the therapy more than 90 days are not excluded.
5) Patients who took cytapheresis in 2 weeks before that day.
6) Patients who took antidiarrheal or antispasmodic drugs after screening examination.
7) Patients who used nicotine patch, received antibiotics and any product containing omega-3 fatty acids within the last 7 days.
8) Patients who is participated other clinical trials.
9) Patients who have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the deylayed-release mesalazine tablets.
10) Patients who have a history of serious adverse event to mesalazine.
11) Patients who have renal or hepatic diseases.
12) Patients whose stool examination positive for Clostridium difficile, bacterial pathogens, or ova and parasites.
13) Patients who have a history of alcohol abuse.
14) Patients who were diagnosed malignant neoplasms.
15) Patients who were pregnant and/or lactating women.
16) Patients who are having an effect of the adverse event by an investigational new drug (or a drug in Phase IV) in other clinical trial previously.
17) Patients who were considered unsuitable for this study by participant doctors.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoo Nakagawa
Organization Chiba University Hospital
Division name Division of Gastroenterology
Zip code
Address 1-8-1 Inohana Chuo-Ku, Chiba city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University Hospital
Division name Division of Gastroenterology
Zip code
Address 1-8-1 Inohana Chuo-Ku Chiba city
TEL
Homepage URL
Email

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization Chiba University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2013 Year 06 Month 10 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
2013 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 08 Day
Last modified on
2015 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012720

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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