UMIN-CTR Clinical Trial

Public title

Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis

Acronym

Randomized controlled study for concomitant use of 5-ASA suppository with increased dose of oral 5-ASA for moderate to severe patients with ulcerative colitis

Scientific Title

Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis

Scientific Title:Acronym

Randomized controlled study for concomitant use of 5-ASA suppository with increased dose of oral 5-ASA for moderate to severe patients with ulcerative colitis

Region

Japan

Condition

ulcerative colitis

Classification by specialty

Medicine in general

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We conduct a prospective, multicenter randomized controlled study involving patients with moderate to severe patients who receive 5-ASA suppository or not when oral 5-ASA is increased.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The change in partial Mayo score after 4 weeks of therapy

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Arm A: Increase of oral 5-ASA (oral administration of 5-ASA in a maximum dose for 8 weeks)

Interventions/Control_2

Arm B: Increase of oral 5-ASA and addition of 5-ASA suppository (oral administration of 5-ASA in a maximum dose for 8 weeks and topical administration of 1 g of 5-ASA suppository for 4 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

Age-lower limit

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Moderate to severe activity (total Mayo score of 3-8) with administrating maintenance dose of oral 5-ASA (not greater than 3.0g of Pentasa or 2.4 g of Asacol).

Rectal inflammation with Mayo endoscopic subscore of 1 or more.

Key exclusion criteria

Coexisting infectious colitis
History of administrating more than 3.0 g of oral 5-ASA, topical 5-ASA, oral corticosteroid, tacrolimus before 30 days of enrollment
History of receiving anti-TNF therapy before 60 days of enrollment
Regularly administrating NSAIDs before 7 days of enrollment
History of administrating topical corticosteroid before 7 days of enrollment
Severe renal/liver dysfunction
History of allergy for 5-ASA
Concomitant malignant disease
With pregnancy or lactation
Judged as inadequate for this study by the researchers

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuo Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3621

Email

takehara@gh.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yuko Sakakibara

Organization

National Hospital Organization Osaka National Hospital

Division name

Department of Gastroenterology

Zip code

Address

2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan

TEL

06-6942-1331

Homepage URL

Email

yuko.s@onh.go.jp

Institute

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

14473

Org. issuing International ID_1

Ethics Committee of Osaka University Hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

01

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

2015

Year

08

Month

11

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

10

Day

Last modified on

2018

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022309