UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the efficacy of 5ASA oral formula and suppository against relapse of proctitis
Title of the study (Brief title)	Oral vs. suppository 5ASA against relapse of proctitis
Region	Japan

Condition
Condition	proctitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of remission induction in relapsed proctitis between 5ASA suppository and 5ASA oral formula
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	improvement in endoscopic Mayo score 4 weeks after the intervention
Key secondary outcomes	proportion of patients without relapse of rectal bleeding after 1 year of maintenance therapy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	asacol 3.6g t.i.d 4 weeks
Interventions/Control_2	pentasa suppository 1g/day 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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Having been diagnosed as proctitis by colonoscopy more than 6 months before Having been on maintenance therapy with oral 5ASA (2.4g/day or less), oral sulfasalazine (3g/day or less), sulfasalazine suppository, or 5ASA suppository(1 in two days or less), or no maintenance therapy, which has not been changed for at least 2 months prior to the study entry Bleeding Mayo score > 0 Given written informed consent Eendoscopic Mayo score > 0 No active inflammation in area more than 15cm from the anal verge on colonoscopy
Key exclusion criteria	Pregnant or nursing female Patients who received steroids, immunosuppressants, immunomodulators, anti-TNF alpha, or leucocytapheresis within 3 months before the study entry Those with severe liver or renal dysfunction Those with a history of hypersensitivity against mesalazine Those who were regarded inadequate for this study
Target sample size	140

Research contact person
Name of lead principal investigator	Nobuyuki Matsuhashi
Organization	NTT Medical Center Tokyo
Division name	Dept of Gastroenterology
Address	5-9-22 Higashigotanda Shinagawa-ku, Tokyo
TEL	03-3448-6245
Email	nmatuha-tky@umin.ac.jp

Public contact
Name of contact person	Nobuyuki Matsuhashi
Organization	NTT Medical Center Tokyo
Division name	Dept of Gastroenterology
Address	5-9-22 Higashigotanda Shinagawa-ku, Tokyo
TEL	03-3448-6245
Homepage URL
Email	nmatuha-tky@umin.ac.jp

Sponsor
Institute	NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2014 Year 08 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 12 Day
Anticipated trial start date	2014 Year 08 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

Management information
Registered date	2014 Year 08 Month 12 Day
Last modified on	2018 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017111