UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031055
Receipt number R000035462
Scientific Title Impact of varenicline on gastric emptying and effect of domperidone in healthy adults
Date of disclosure of the study information 2018/01/30
Last modified on 2019/01/31 13:43:48

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Basic information

Public title

Impact of varenicline on gastric emptying and effect of domperidone in healthy adults

Acronym

varenicline and gastric emptying

Scientific Title

Impact of varenicline on gastric emptying and effect of domperidone in healthy adults

Scientific Title:Acronym

varenicline and gastric emptying

Region

Japan


Condition

Condition

functional gastrointestinal disorder

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Varenicline, a nicotinic receptor agonist, is an agent that is frequently used to help smokers quit smoking. This medicine sometimes occurs gastrointestinal symptoms, although the mechanism remains uncertain. The purpose of the study is to clarify the impact of varenicline and domperidone, a novel antiemetic drug, on gastric emptying of healthy adults, using 13C gastric emptying breath test.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of gastric parameters (gastric emptying parameter, t-half) among different pretreatments (control, varenicline, domperidone, varenicline with domperidone)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

no pretreatment (control)

Interventions/Control_2

pretreatment of varenicline 0.5mg

Interventions/Control_3

pretreatment of domperidone 10mg

Interventions/Control_4

pretreatment of varenicline 0.5mg with domperidone 10mg

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

50 years-old >=

Gender

Male

Key inclusion criteria

Adults not having gastrointestinal symptoms, and not taking prescription of gastrointestinal drugs or anti-psychological drugs.

Key exclusion criteria

Adults with current gastrointestinal disorders or past history of upper gastrointestinal operation.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takatsugu Yamamoto

Organization

Teikyo University School of Medicine

Division name

Department of Internal Medicine

Zip code


Address

2-11-1, Kaga, Itabashi-ku, Tokyo

TEL

03-3964-1211

Email

ymmt@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takatsugu Yamamoto

Organization

Teikyo University School of Medicine

Division name

Department of Internal Medicine

Zip code


Address

2-11-1, Kaga, Itabashi-ku, Tokyo

TEL

03-3964-1211

Homepage URL


Email

ymmt@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University

Institute

Department

Personal name



Funding Source

Organization

Teikyo University

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


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



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 30 Day


Related information

URL releasing protocol


Publication of results

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

Completed

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 12 Month 15 Day

Last follow-up date

2018 Year 10 Month 31 Day

Date of closure to data entry

2018 Year 10 Month 31 Day

Date trial data considered complete

2018 Year 10 Month 31 Day

Date analysis concluded

2019 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 30 Day

Last modified on

2019 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035462


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name