UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis
Title of the study (Brief title)	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	Yohko Murakawa
Organization	Shimane University
Division name	Faculty of Medicine, Third Department of Internal Medicine
Address	89-1 Enya-cho, Izumo, Shimane
TEL	0853-20-2196
Email	murakawa@med.shimane-u.ac.jp

Public contact
Name of contact person	Mayuko Moriyama
Organization	Shimane University Hospital
Division name	Department of Rheumatology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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