UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022954
Receipt number R000026384
Scientific Title A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
Date of disclosure of the study information 2016/07/05
Last modified on 2021/01/05 23:44:19

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Basic information

Public title

A study related to usability of Mesalazine Controlled-Release Tablets and Granules.

Acronym

A study related to usability of Mesalazine Controlled-Release Tablets and Granules.

Scientific Title

A study related to usability of Mesalazine Controlled-Release Tablets and Granules.

Scientific Title:Acronym

A study related to usability of Mesalazine Controlled-Release Tablets and Granules.

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1. To compare usability of Mesalazine Controlled-Release Tablets and Granules
2. To evaluate the impact of the usability on adherence, efficacy, and safety

Basic objectives2

Others

Basic objectives -Others

usability

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Differences in usability between Mesalazine Controlled-Release Tablets and Granules(by questionnaire)

Key secondary outcomes

adherence(by questionnaire)
changes in subjective symptoms,concomitant medications, Lichtiger Score, Mayo Score
occurence of side effect
(during the period of taking tablets or granules)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks

Interventions/Control_2

Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 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


Not applicable

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

1.patients who are considered to be appropriate to take mesalazine controlled-release tablets and granules
2.patients who considered to be able to evaluate usability of medication
3.patients from whom written informed consent was obtained

Key exclusion criteria

Patients who do not meet the above criteria

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Taku
Middle name
Last name Kobayashi

Organization

Kitasato University Kitasato Institute Hospital

Division name

Kitasato University Kitasato Institute Hospital

Zip code

1088642

Address

5-9-1 Shirokane, Minato-ku, Tokyo

TEL

03-3444-6161

Email

kobataku@insti.kitasato-u.ac.jp


Public contact

Name of contact person

1st name Keiji
Middle name
Last name Yagisawa

Organization

Kitasato University Kitasato Institute Hospital

Division name

Kitasato University Kitasato Institute Hospital

Zip code

108-8642

Address

5-9-1 Shirokane, Minato-ku, Tokyo

TEL

03-3444-6161

Homepage URL


Email

k-yagi@insti.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University Kitasato Institute Hospital

Institute

Department

Personal name



Funding Source

Organization

Kitasato University Kitasato Institute Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kitasato University Kitasato Institute Hospital

Address

5-9-1 Shirokane, Minato-ku, Tokyo

Tel

03-3444-6161

Email

kenkyu@insti.kitasato-u.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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 05 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361024/

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361024/

Number of participants that the trial has enrolled

49

Results

Thirty three patients were included in the analysis. Significantly more patients found the tablets to be less acceptable than the granules. The granules were preferable to the tablets when the 2 formulations were compared directly. The adherence rate was slightly better among patients taking the granules during the observation period, but the difference was not significant.

Results date posted

2021 Year 01 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Outpatients diagnosed with UC at Kitasato University Kitasato Institute Hospital or Kyorin University Hospital and who were eligible for CR mesalazine were recruited from January to December 2016 in Kitasato University Kitasato Institute Hospital, and from April to August 2017 in Kyorin University Hospital. There was no age limit as long as the patients could assess the acceptability of the medications and answer the questionnaires unaided.

Participant flow

UC patients were randomly assigned to 2 groups in a 1:1 ratio. Patients in each group took either 4 g of CR mesalazine tablets or granules for 6 to 9 weeks, and then switched to 4 g of the other formulation for a further 6 to 9 weeks.

Adverse events

Most patients experienced no adverse events related to CR mesalazine during the study period. One patient who had taken CR mesalazine tablets before enrollment experienced deterioration of abdominal symptoms during the granule period and improved after switching to the tablets.

Outcome measures

This study aimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossover questionnaire survey.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 01 Month 08 Day

Date of IRB

2016 Year 01 Month 12 Day

Anticipated trial start date

2016 Year 01 Month 15 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 06 Month 30 Day

Last modified on

2021 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026384


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name