UMIN-CTR Clinical Trial

Public title

Efficacy and safety of extended administration by max dose mesalamine on induction therapy for mild to moderate ulcerative colitis

Acronym

CATHEDRAL study

Scientific Title

Efficacy and safety of extended administration by max dose mesalamine on induction therapy for mild to moderate ulcerative colitis

Scientific Title:Acronym

CATHEDRAL study

Region

Japan

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This is an observational study of multi center cohort to assess the therapeutic efficacy and safety of extended administration by max dose oral 5-aminosalicylic acid (5ASA) on induction therapy in patients with mild to moderately active ulcerative colitis (UC). Prospectively designed standardized follow-up schedule was used for the follow-up of patients by experienced clinicians in this study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

1.Change in remission rate in study population with time. Clinical remission was defined as the status in SCCAI score<=2.

Key secondary outcomes

1.Change in response rate in study population with time.Clinical response was defined as the status in decrease in SCCAI score by>=2 points in comparison to initial SCCAI.
2.Change in SCCAI score in study population with time.
3.Adverse effect

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

13

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Ulcerative colitis patients within three years after diagnosis.
2. Patients with ulcerative colitis in active who meet the following criteria in Mayo score.

(1) Mayo score(Full):3-9
(2) Mayo index:Mucosa>=1
(3) Mayo index:Rectal bleeding>=1
(4) Mayo index:Physician's global assessment<=2

3. Ulcerative colitis patients who are going to include induction therapy by oral 5-aminosalicylic acid(5ASA),including patients who have been relapsed during maintenance therapy in oral 5ASA administration.
4. Patients aged 13 or older.
5. Patients who were able to provide written informed consent before being included this study. In the case the proxy provide written informed consent, the proxy should be a person judged capable of representing the intents and best interests of the patient.

Key exclusion criteria

1. Patients who had been treated with topical therapy (enema, suppository) within one month at the study inclusion.
2. Patients who have been treating by oral steroid, immunomodulator,Immunosuppresser (Tacrolimus), Cytapheresis, Biologics in their clinical relapse phase within one month at the study inclusion.
3. Patients with Crohn's disease.
4. Patients with gastric ulcer.
5. Patients with history of intestinal surgery.
6. Patients with pathogenic bacterium in stool examined by stool culture inspection.
7. Patients with allergy to Mesalazine.
8. Patients with allergy to Salicylic acid.
9. Patients with severe renal failure: eGFR<30 mL/min/1.73 m*2.
10. Patients with severe liver failure: AST or ALT>3 times of the upper limit of normal.
11. Patients who have been included other clinical trial.
12. Patients who is determined inappropriate to include to this study by the investigator.
*Clinically relapse is defined as the phase in SCCAI score increased from<=2 to 3>=.

Target sample size

150

Name of lead principal investigator

1st name	Shiro
Middle name
Last name	Nakamura

Organization

Hyogo College of Medicine

Division name

Department of Inflammatory Bowel Disease, Division of Internal Medicine

Zip code

663-8501

Address

1-1, Mukogawa, Nishinomiya, Hyogo, 6638501

TEL

0798-45-6660

Email

shiro@hyo-med.ac.jp

Name of contact person

1st name	Takako
Middle name
Last name	Miyazaki

Organization

Hyogo College of Medicine

Division name

Department of Inflammatory Bowel Disease, Division of Internal Medicine

Zip code

663-8501

Address

1-1, Mukogawa, Nishinomiya, Hyogo, 6638501

TEL

0798-45-6663

Homepage URL

Email

takako35@hyo-med.ac.jp

Institute

Department of Inflammatory Bowel Disease, Division of Internal Medicine
Hyogo College of Medicine

Institute

Department

Personal name

Organization

MOCHIDA PHARMACEUTICAL CO.,LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Hyogo College of medicine, Independent Ethics Committee

Address

1-1, Mukogawa, Nishinomiya, Hyogo,

Tel

0798-45-6164

Email

rinri@hyo-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

兵庫医科大学病院（兵庫県）大阪市立総合医療センター（大阪府），堂島内科・消化器内科クリニック（大阪府）、大阪市立大学（大阪府）、東住吉森本病院（大阪府）、西下胃腸病院（大阪府）、若草第一病院（大阪府）、府中病院（大阪府）、青山内科クリニック（兵庫県），藤田胃腸科病院（大阪府），うえだクリニック（大阪府），製鉄記念広畑病院（兵庫県）、淀川キリスト教病院（大阪府），大阪市立十三市民病院（大阪府），馬場記念病院（大阪府），浅香山病院（大阪府），よしの内科クリニック（大阪府），むらのクリニック（大阪府）

Date of disclosure of the study information

2018

Year

06

Month

12

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

Enrolling by invitation

Date of protocol fixation

2018

Year

04

Month

02

Day

Date of IRB

2018

Year

05

Month

10

Day

Anticipated trial start date

2018

Year

06

Month

12

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Products in this study:
1. Mesalazine
Pentasa(Tab)250mg
Pentasa(Tab)500mg
Pentasa(Gra94%)
Asacol(Tab)400mg
Lialda(Tab)1200mg
2. Salazosulfapyridine
Salazopyrine(Tab)500mg(including generic drug)

Study period
Registration:2018/5/10-2019/12/31
Ovservation: From registration to
48w after induction therapy beginning.

Ovservation items
Patient's background (on screening)
hospital ID, date of birth, gender, age, height, body weight, allergy, smoking history, complications, medical history, inpatient or outpatient, medical history of Ulcerative colitis:onset, history of relapse, latest relapse.

Administration of 5ASA (period: from one month before induction therapy beginning to end of observation period)
product name, dose/day, times/day, day of first administration, day of final administration, day of termination, reason of termination, adherence

Other items
Medical therapy history for ulcerative colitis(on screening)

Concomitant medications
Adverse effect
(period: from beginning of induction therapy to end of observation period)

Clinical examination
stool culture inspection (Clostridium difficile rapid test), blood test,Biochemical l test, Calprotectin test

Disease activity
SCCAI score (timing: at the beginning of induction therapy, 2w, 4w, 8w, 12w, 16w, 24w, 32w, 48w, at the termination)
Mayo score (timing: On screening, at the end of observation period)

Registered date

2018

Year

06

Month

12

Day

Last modified on

2019

Year

06

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037493