UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010168
Receipt number R000011906
Scientific Title Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC)
Date of disclosure of the study information 2013/03/08
Last modified on 2013/03/05 17:25:29

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Basic information

Public title

Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC)

Acronym

Segmental Endoscopic Evaluation in patients with mild-to-moderate UC

Scientific Title

Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC)

Scientific Title:Acronym

Segmental Endoscopic Evaluation in patients with mild-to-moderate UC

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate endoscopic improvement in UC patients treated with combination of oral and topical mesalazine by segmental endoscopic evaluation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Mucosal healing defined as Mayo endoscopic score = 0, 1

Key secondary outcomes

Endoscopic improvement by segmental endoscopic evaluation

Improvement of disease activity in UCDAI score and/or UCDAI sub-scores


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Combination therapy of oral Pentasa 4g/day with Pentasa enema 1g/day for 8 weeks

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

15 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients with active mild-to-moderate UC
2) Patients treated with oral mesalazine (&#8804; 4g/day) or oral sulfasalazine (&#8804; 4.5g/day)

Key exclusion criteria

1)Patients receiving topical mesalazine, topical sulfasalazine within 14 days prior to study entry
2)Patients receiving any steroid within 14 days prior to study entry
3)Patients treated with immunosuppressive agents or anti TNF-a antibody during 90 days prior to study enrolment
4)Patients receiving cytapheresis within 14 days prior to study entry
5)Patients who have allergy to salicylates
6)Patients who have experienced serious adverse effect elicited by mesalazine
7)Patients who have complicated malignant disease
8)Patients who are pregnant or possibly pregnant
9)Patients suspected to remain the effect of intervention in other clinical researches
10)Patients who have any condition that might interfere with study assessments, judged by the investigator.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Suzuki

Organization

Toho University Sakura Medical Center

Division name

Gastroenterology Center

Zip code


Address

564-1, Shimosizu Sakura, Chiba 285-8741, Japan

TEL

043-462-8811

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuo Suzuki

Organization

Toho University Sakura Medical Center

Division name

Gastroenterology Center

Zip code


Address

564-1, Shimosizu Sakura, Chiba 285-8741, Japan

TEL

043-462-8811

Homepage URL


Email

yasuo-suzuki@sakura.med.toho-u.ac.jp


Sponsor or person

Institute

Toho University Sakura Medical Center

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

成田赤十字病院(千葉県)
東京慈恵会医科大学付属柏病院(千葉県)
津田沼中央病院
東葛辻仲病院
千葉大学医学部付属病院(千葉県)
東京歯科大学市川総合病院
セコメディック病院
社会保険船橋中央病院


Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2011 Year 03 Month 05 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date

2012 Year 12 Month 01 Day

Date of closure to data entry

2013 Year 01 Month 01 Day

Date trial data considered complete

2013 Year 02 Month 01 Day

Date analysis concluded

2013 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 03 Month 05 Day

Last modified on

2013 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011906


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name