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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026859
Receipt No. R000030742
Scientific Title Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis
Date of disclosure of the study information 2017/04/05
Last modified on 2017/04/04

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Basic information
Public title Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis
Acronym Therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in SSC
Scientific Title Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis
Scientific Title:Acronym Therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in SSC
Region
Japan

Condition
Condition systemic sclerosis
Classification by specialty
Gastroenterology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to compare of effectiveness of acotinamide hydrochloride and trimebutine maleateon for gastro-esophagial symptoms in systemic sclerosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes tally a questionnaire survey; general assessment of the degree of improvement or deterioration of gastro-esophageal symptom at 4W and 8W
Key secondary outcomes assessment of each question in a questionnaire.

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 acotinamaide hydrpchloride
100 mg tablets, 3 times/day, 28 days
Interventions/Control_2 trimebutine maleateon
100 mg tablets, 3 times/day, 28 days
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with systemic sclerosis (both lc-SSc and dc-SSc) who have symptoms esophgial dysfunction.
The patients satisfied the SSc criteria 2007 by the Specified Disease Treatment Research Program based on the Health Service Bureau of the Ministry of Health, Labour and Welfare.
Key exclusion criteria 1) the patients who have taken proton pomp inhibitor or vonoprazan within 2 months.
2) the patients who have sensitivity against acotinamide hydrochloride or trimebutine maleateon
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohko Murakawa
Organization Shimane University
Division name Faculty of Medicine, Third Department of Internal Medicine
Zip code
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2196
Email murakawa@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayuko Moriyama
Organization Shimane University Hospital
Division name Department of Rheumatology
Zip code
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2197
Homepage URL
Email mmayuko@med.shimane-u.ac.jp

Sponsor
Institute Third Department of Internal Medicine (Department of Rheumatology) Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Third Department of Internal Medicine (Department of Rheumatology) Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese Cross Society Matsue JCS Hospital
Shimane Prefecture central Hospital
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 島根大学医学部附属病院(島根県)、島根県立中央病院(島根県)、松江赤十字病院(島根県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 05 Day

Related information
URL releasing protocol
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
2017 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 04 Day
Last modified on
2017 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030742

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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