UMIN-CTR Clinical Trial

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

Ulcerative Colitis

Classification by specialty

Gastroenterology

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Clinical response rate at week 24 by UCDAI score

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

Chiba University Hospital

Institute

Department

Personal name

Organization

Chiba University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

2013

Year

06

Month

10

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

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 related information

Registered date

2013

Year

06

Month

08

Day

Last modified on

2015

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012720