UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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
Condition	ulcerative colitis
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	The change in partial Mayo score after 4 weeks of therapy
Key secondary outcomes

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3621
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Yuko Sakakibara
Organization	National Hospital Organization Osaka National Hospital
Division name	Department of Gastroenterology
Address	2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan
TEL	06-6942-1331
Homepage URL
Email	yuko.s@onh.go.jp

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

Funding Source
Organization	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
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
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 10 Day
Last modified on	2018 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022309