UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053000
Receipt number R000060463
Scientific Title A Randomized, Placebo-Controlled, Double-Blind, Crossover Comparative Study of the Effect of Acotiamide on Gastrointestinal Symptoms in Patients with Myasthenia Gravis
Date of disclosure of the study information 2023/12/05
Last modified on 2023/12/05 09:45:37

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Basic information

Public title

A Randomized, Placebo-Controlled, Double-Blind, Crossover Comparative Study of the Effect of Acotiamide on Gastrointestinal Symptoms in Patients with Myasthenia Gravis

Acronym

ACTMG

Scientific Title

A Randomized, Placebo-Controlled, Double-Blind, Crossover Comparative Study of the Effect of Acotiamide on Gastrointestinal Symptoms in Patients with Myasthenia Gravis

Scientific Title:Acronym

ACTMG

Region

Japan


Condition

Condition

Myasthenia Gravis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy of acotiamide in the treatment of gastrointestinal symptoms in patients with myasthenia gravis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Superiority of the rate of improvement of dyspepsia symptoms with acotiamide over placebo during the first 4 weeks of oral administration

Key secondary outcomes

Superiority of the rate of improvement of dyspepsia symptoms with acotiamide over placebo at weeks 1, 2, and 3 after initiation of oral therapy. Incidence of adverse effects and change in MG symptoms with acofide (MG-ADL, MG-QOL, MG composite)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Acotiamide should be administered orally, one 100 mg tablet three times a day before meals. Placebo will be administered in the same manner.
The dosing period will consist of 28 consecutive days of administration of one drug followed by a 28-day rest period, followed by 28 consecutive days of administration of the drug that is not being taken.

Interventions/Control_2

Acotiamide should be administered orally, one 100 mg tablet three times a day before meals. Placebo will be administered in the same manner.
The dosing period will consist of 28 consecutive days of administration of one drug followed by a 28-day rest period, followed by 28 consecutive days of administration of the drug that is not being taken.

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

18 years-old <=

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed with myasthenia gravis
Patients with one or more symptoms of dysphagia, postprandial bloating, early satiety, upper abdominal pain, or upper abdominal discomfort for at least 6 months prior to obtaining consent
Patients who have undergone upper gastrointestinal endoscopy within 6 months of obtaining consent and no lesions causing gastrointestinal symptoms were found.
Patients who have not used acotiamide within 3 months of obtaining consent
Patients who are at least 18 years old and able to understand and consent to the study by themselves.

Key exclusion criteria

Patients under 18 years of age at the start of treatment
Patients with obvious organic disease as a possible cause of dysphagia, postprandial bloating, early satiety, epigastric pain, or epigastric discomfort.
Patients with acothiaminergic allergies
Patients who are allergic to acotiamide.
Other patients whose inclusion in the study is deemed inappropriate by the investigator.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Mori

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Email

koyamaru2002@yahoo.co.jp


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Mori

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Homepage URL


Email

koyamaru2002@yahoo.co.jp


Sponsor or person

Institute

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, SHinjuku-ku, Tokyo

Tel

0333531211

Email

med-rinri-jimu@adst.keio.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

2023 Year 12 Month 05 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi

Publication of results

Unpublished


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

Preinitiation

Date of protocol fixation

2023 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2024 Year 09 Month 01 Day

Last follow-up date

2030 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 12 Month 05 Day

Last modified on

2023 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060463


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name