UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021555
Receipt number R000024834
Scientific Title Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)
Date of disclosure of the study information 2016/03/31
Last modified on 2018/09/25 08:41:18

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Basic information

Public title

Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)

Acronym

Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)

Scientific Title

Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)

Scientific Title:Acronym

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

1st name
Middle name
Last name Mikihiro Fujiya

Organization

Asahikawa Medical University

Division name

Division of Gastroenterology and Hematology/Oncology, Department of Medicine

Zip code


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

1st name
Middle name
Last name Mikihiro Fujiya

Organization

Asahikawa Medical University

Division name

Division of Gastroenterology and Hematology/Oncology, Department of Medicine

Zip code


Address

2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido, Japan

TEL

81-166-68-2462

Homepage URL


Email

fjym@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 31 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

Completed

Date of protocol fixation

2016 Year 03 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024834


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name