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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026579
Receipt No. R000030520
Scientific Title Pharmacokinetics of mianserin suppository in Japanese elderly healthy volunteers -a pilot study
Date of disclosure of the study information 2017/03/16
Last modified on 2020/03/22

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Basic information
Public title Pharmacokinetics of mianserin suppository in Japanese elderly healthy volunteers -a pilot study
Acronym Pharmacokinetics of mianserin suppository in healthy volunteers
Scientific Title Pharmacokinetics of mianserin suppository in Japanese elderly healthy volunteers -a pilot study
Scientific Title:Acronym Pharmacokinetics of mianserin suppository in healthy volunteers
Region
Japan

Condition
Condition delirium
Classification by specialty
Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the pharmacokinetics of a single rectal administration of mianserin 20 mg suppository in elderly healthy volunteers
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics parameters (area under the blood concentration time curve, maximum drug concentration, time of maximum drug concentration, half-life)
Key secondary outcomes

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 A single dose of mianserin 30 mg suppository will be rectally administered
Blood sampling will be conducted 7 times (at pre, 0.5, 1, 2, 4, 6, 8, 10, 24, 36, 48 hours).
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
65 years-old <=
Age-upper limit
76 years-old >
Gender Male
Key inclusion criteria Healthy volunteers enrolled this study must be agreement with the following criteria:
1. Age between 65 and 75
2. Male
3. Subjects are competent to consent, keep the rule of this study and are able to report self condition
4. Subjects who are judged eligible by the investigator in several series of medical check
Key exclusion criteria 1. Subjects who have inappropriate medical history (ex., drug abuse, alcoholism, any kind of heart, liver, kidney, lung, eye, blood diseases and digestive system disorder, etc.) or who are ingested medicines during this study.
2. Smoker.
3. Any drug allergy.
4. Subjects who are using excessive alcohol regularly (cannot keep abstinence for study period).
5. Participation in any clinical trial within the last 3 months.
6. Subjects who are inadequate for enrollment judged by the investigators.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Nawata
Organization Showa University
Division name School of Pharmacy
Zip code 142-8555
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555.
TEL 03-3784-8000
Email nawa_shu@cmed.showa-u.ac.jp

Public contact
Name of contact person
1st name Shuchi
Middle name
Last name Nawata
Organization Showa University
Division name School of Pharmacy
Zip code 142-8555
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555.
TEL 03-3784-8000
Homepage URL
Email nawa_shu@cmed.showa-u.ac.jp

Sponsor
Institute Department of Hospital Pharmaceutics
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Clinical Research Institute for Clinical Pharmacology and Therapeutics
Showa University Karasuyama Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization lnstitutional Review Board of ShowaUniversity Karasuyama Hospital
Address 6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo,157-8577 Japan
Tel 03-3300-5231
Email scri@ofc.showa-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 昭和大学附属烏山病院内 昭和大学臨床薬理研究所(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 16 Day

Related information
URL releasing protocol http://www.showa-u.ac.jp/SUHK/guide/irb/report.html
Publication of results Published

Result
URL related to results and publications http://www.jscpt.jp/journal/pdf/j50_2.pdf
Number of participants that the trial has enrolled 3
Results The effects of 20mg mianserin suppositories were evaluated in three healthy older male adults. Mianserin concentration in blood was measured using gas chromatography-mass spectrometry. tmax was 14.7(8.1)h; Cmax was 7.0
(1.4)ng mL; AUC0-48 was 196.7(19.6)h ng/mL
Results date posted
2020 Year 03 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics healthy older male adults
Participant flow Open call for participants
Adverse events no
Outcome measures pharmacokinetics of mianserin suppositories
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 12 Day
Date of IRB
2017 Year 04 Month 14 Day
Anticipated trial start date
2017 Year 02 Month 17 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 16 Day
Last modified on
2020 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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