UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022993
Receipt number R000026502
Scientific Title The usefulness of high-concenrate magnesium citrate solution for colonic preparation before colonoscopy
Date of disclosure of the study information 2016/07/03
Last modified on 2019/01/04 18:41:28

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Basic information

Public title

The usefulness of high-concenrate magnesium citrate solution for colonic preparation before colonoscopy

Acronym

The usefulness of high-concenrate magnesium citrate solution for colonic preparation before colonoscopy

Scientific Title

The usefulness of high-concenrate magnesium citrate solution for colonic preparation before colonoscopy

Scientific Title:Acronym

The usefulness of high-concenrate magnesium citrate solution for colonic preparation before colonoscopy

Region

Japan


Condition

Condition

Appropriate indication to colonoscopy

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this single center study is to evaluate the usefulness of high-concentrate magnesium citrate solution for colonic preparation before colonoscopy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Degree of colon cleansing: Bowel cleansing was assessed by colonoscopist. The degree of colon cleansing was recorded for each bowel segment (rectum, sigmoid colon, descending colon, transverse colon, ascending colon/rectum ). Each segments was recorded into 4 categories (excellent, good, poor, inadequate).

Key secondary outcomes

Acceptability. Adverse events; Any adverseevents related to bowel preparation(abdominal pain, nausea, vomiting, etc) were reported by the endoscopic technician. All participants were monitored for adverse events during colonoscopy.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

Central registration


Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

high-concentrate magnesium citrate administration

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1)The outpatient whom colonoscopic examination is performed in
(2)The patients that an inclusion agreement is obtained in response to the explanation that is enough for this study by a chief physician

Key exclusion criteria

(1)The patients who are contraindicated to colonoscopic examination
* The patients with the intestinal perforation, acute bleeding, general debility
* The patients with the inflammatory disorder with ulcerative colitis, Crohn's disease
* The patients (including colorectal cancer and the benign disease) with the intestinal stenosis
* The patients with a history of stomach or the intestinal resection
* The patients with active cancer
* Including the treatment for other carcinomas, it is the patient with a history of the radiotherapy to the upper quadrant
* With the pregnant likelihood during the pregnancy or the women whom we are nursing
* The patients considered that we are complicated with psychosis or psychiatric symptoms, and the participation in study is difficult
* In addition, the patients who are found with complications serious
(2)The patients who are contraindicated to a use drug
* To gastrointestinal tract with obstruction or the patients whom there is the suspicion and the patients with the induration service with serious case
* The patients with suspected acute abdomen
* The patients (abnormal value of the Cr) with the renal failure
* The patients with toxic megacolon
* It is the patient with a history of hypersensitivity to the ingredient of the use drug
(3)In addition, the patients who judged that doctor attending was inadequate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takasi Abe

Organization

Takarazuka Municipal Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

4-5-1, Kohama, Takarazuka, Hyogo 665-0827,Japan

TEL

0797-87-1171

Email

canceribd@tcn.zaq.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironori Tanaka

Organization

Takarazuka Municipal Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

4-5-1, Kohama, Takarazuka, Hyogo 665-0827,Japan

TEL

0797-87-1171

Homepage URL


Email

hironori4951@hotmail.co.jp


Sponsor or person

Institute

Takarazuka Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Horii Pharmaceutical Ind.,Ltd

Organization

Division

Category of Funding Organization

Other

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

宝塚市立病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


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 07 Month 07 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 07 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 07 Month 03 Day

Last modified on

2019 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026502


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/12/15 161215UMIN登録_マグP準高張液試験全データ.xlsx