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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022993
Receipt No. 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

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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
Institute Takarazuka Municipal Hospital
Institute
Department

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
URL(English) https://upload.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


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