UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)
Title of the study (Brief title)	Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of polyphosphate in the treatment of ulcerative colitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency and grade of adverse events due to 4-week administration of polyphosphate for the treatment of ulcerative colitis
Key secondary outcomes	Efficacy of 4-week administration of polyphosphate for improvements in clinical and histological inflammation and the expressions of pro-inflammatory cytokines in the treatment of ulcerative colitis

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	Oral administration of polyphosphate Step 1 300mg/day of polyphosphate, after meal in the mornig everyday for 28 days Step 2 1000mg/day of polyphosphate, after meal in the morning everyday for 28 days
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with refractory ulcerative colitis (Mayo score, 3 to 8; rectal bleeding score, 1 or more; endoscopic subscore, 2 or more)
Key exclusion criteria	Patients with drug allergies, renal failure, liver dysfunction, malignancies, pregnancy, history of bowel surgery, infectious colitis, irritable bowel disease, hyperthyroidism or hyperphosphatemia Patients who are judged to be ineligible by the chief study conductor or doctor in charge
Target sample size	10

Research contact person
Name of lead principal investigator	Mikihiro Fujiya
Organization	Asahikawa Medical University
Division name	Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Address	2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL	81-166-68-2462
Email	fjym@asahikawa-med.ac.jp

Public contact
Name of contact person	Mikihiro Fujiya
Organization	Asahikawa Medical University
Division name	Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Address	2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL	81-166-68-2462
Homepage URL
Email	fjym@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 14 Day
Anticipated trial start date	2016 Year 04 Month 20 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	2016 Year 03 Month 22 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024834