Unique ID issued by UMIN | UMIN000022954 |
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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 |
A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
A study related to usability of Mesalazine Controlled-Release Tablets and Granules.
Japan |
ulcerative colitis
Hepato-biliary-pancreatic medicine |
Others
NO
1. To compare usability of Mesalazine Controlled-Release Tablets and Granules
2. To evaluate the impact of the usability on adherence, efficacy, and safety
Others
usability
Exploratory
Pragmatic
Not applicable
Differences in usability between Mesalazine Controlled-Release Tablets and Granules(by questionnaire)
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)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Patients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks
Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 weeks
Not applicable |
100 | years-old | > |
Male and Female
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
Patients who do not meet the above criteria
60
1st name | Taku |
Middle name | |
Last name | Kobayashi |
Kitasato University Kitasato Institute Hospital
Kitasato University Kitasato Institute Hospital
1088642
5-9-1 Shirokane, Minato-ku, Tokyo
03-3444-6161
kobataku@insti.kitasato-u.ac.jp
1st name | Keiji |
Middle name | |
Last name | Yagisawa |
Kitasato University Kitasato Institute Hospital
Kitasato University Kitasato Institute Hospital
108-8642
5-9-1 Shirokane, Minato-ku, Tokyo
03-3444-6161
k-yagi@insti.kitasato-u.ac.jp
Kitasato University Kitasato Institute Hospital
Kitasato University Kitasato Institute Hospital
Other
Kitasato University Kitasato Institute Hospital
5-9-1 Shirokane, Minato-ku, Tokyo
03-3444-6161
kenkyu@insti.kitasato-u.ac.jp
NO
2016 | Year | 07 | Month | 05 | Day |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361024/
Published
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361024/
49
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.
2021 | Year | 01 | Month | 05 | Day |
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.
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.
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.
This study aimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossover questionnaire survey.
Completed
2016 | Year | 01 | Month | 08 | Day |
2016 | Year | 01 | Month | 12 | Day |
2016 | Year | 01 | Month | 15 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2016 | Year | 06 | Month | 30 | Day |
2021 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026384
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