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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032961
Receipt No. R000037493
Official scientific title of the study Efficacy and safety of extended administration by max dose mesalamine on induction therapy for mild to moderate ulcerative colitis
Date of disclosure of the study information 2018/06/12
Last modified on 2018/06/10

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Basic information
Official scientific title of the study Efficacy and safety of extended administration by max dose mesalamine on induction therapy for mild to moderate ulcerative colitis
Title of the study (Brief title) 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
16 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):3-8
(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 16 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 of more than 6 weeks after clinically relapse.
2. Patients who had been treated with topical therapy (enema, suppository) within one year at the study inclusion.
3. Patients who have been treating by oral steroid, immunomodulator,Immunosuppresser (Tacrolimus), Cytapheresis, Biologics in their clinical relapse phase.
4. Patients with Crohn's disease.
5. Patients with gastric ulcer.
6. Patients with history of intestinal surgery.
7. Patients in the oral NSAIDs.
8. Patients in the oral aspirin.
9. Patients with pathogenic bacterium in stool examined by stool culture inspection.
10. Patients with allergy to Mesalazine.
11. Patients with allergy to Salicylic acid.
12. Patients with severe renal failure: eGFR<30 mL/min/1.73 m*2.
13. Patients with severe liver failure: AST or ALT>3 times of the upper limit of normal.
14. Patients who have been included other clinical trial.
15. 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 Shiro Nakamura MD. PhD.
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease, Division of Internal Medicine
Address 1-1, Mukogawa, Nishinomiya, Hyogo, 6638501
TEL 0798-45-6660
Email shiro@hyo-med.ac.jp

Public contact
Name of contact person Takako Miyazaki MD. PhD
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease, Division of Internal Medicine
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)

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
2018 Year 06 Month 12 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 02 Day
Anticipated trial start date
2018 Year 06 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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:2018/5/10-2018/11/30
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
2018 Year 06 Month 10 Day


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

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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