UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Title of the study (Brief title)	The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Region	Japan

Condition
Condition	reflux esophagitis associated with systemic scleroderma
Classification by specialty	Clinical immunology Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The efficacy of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma
Key secondary outcomes	The safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma

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	Rabeprazole sodium 1 tablet a day will be added to subjects whose symptom does not improve with 1 tablet a day. The study will continue until subjects meet discontinuance criteria.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with systemic sclerosis who have reflux esophagitis diagnosed by upper gastrointestinal endoscopy or esophagus scintigraphy and daily 10mg of oral rabeprazole sodium is not effective for more than two months. Patients who have no malignant lesions in the upper-gastrointestinal tract confirmed by endoscopy. Patients who give written informed consent.
Key exclusion criteria	Patients who have a severe difficulty swallowing and who are unable to take orally the tablet. Patients who are judged to be inappropriate as a subject by physicians.
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuhito Hamaguchi
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Dermatology
Address	Takaramachi 13-1, Kanazawa
TEL	076-265-2343
Email	yasuhito@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Yasuhito Hamaguchi
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Dermatology
Address	Takaramachi 13-1, Kanazawa
TEL	076-265-2343
Homepage URL
Email	yasuhito@med.kanazawa-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department

Funding Source
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	金沢大学附属病院（石川県）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 03 Month 10 Day
Anticipated trial start date	2005 Year 03 Month 10 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Subject: Patients who visit to Kanazawa University Hospital

Management information
Registered date	2016 Year 01 Month 22 Day
Last modified on	2018 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023888