UMIN-CTR Clinical Trial

Basic information
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
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization	MOCHIDA 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	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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 12 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	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

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)

Management information
Registered date	2018 Year 06 Month 12 Day
Last modified on	2019 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037493