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
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
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
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
