UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001556 |
|---|---|
| Receipt number | R000001873 |
| Scientific Title | The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study |
| Date of disclosure of the study information | 2008/12/10 |
| Last modified on | 2010/07/22 19:19:10 |
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Basic information
Public title
The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Acronym
The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Scientific Title
The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Scientific Title:Acronym
The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the use of mosapride citrate for improving the efficacy and tolerability of bowel preparation with polyethylene glycol electrolyte lavage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tolerability of bowel preparation with polyethylene glycol electrolyte lavage
Key secondary outcomes
quality of bowel preparation, consumption time to take lavage, time to first defecation, time to completion of bowel cleansing, additional volume of lavage to completion of bowel cleansing, occurrence of unpleasant abdominal symptom, and posibility of reduction in requred volume of volume of lavage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Niflec 2000ml with Gasmotin 15mg
Interventions/Control_2
Niflec 2000ml with placebo
Interventions/Control_3
Niflec 1500ml with Gasmotin 15mg
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Out patients who underwent colonoscopy in our hospital
2.patients provided a written informed consent
Key exclusion criteria
1.patients with chronic and acute renal failure (Cr>1.5mg/dl)
2.patients with uncontroled congenital heart failure and unstable angina
3.patients with acute myocardial infarction (AMI) and recieved A-C bypass or intervention for AMI within 3 months
4.abnormal serum sodium, pottassium, phosphorus, and calcium
5.active phase patients with inflammatory bowel disease
6.history of colonic surgery
7.sign of bowel obstruction
8.sign of bowel perforation
9.patients with toxic megacolon
10.patients with suffering from diverticulotitis
11.severe constipatien
12.history of drug allergy
13.sign of pregnancy
14.patients with advanced colorectal cancer
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Tajika |
Organization
Aichi Cancer Center Hospital
Division name
Department of Endoscopy
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya City, 464-8681, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Aichi Cancer Center Hospital
Division name
Department of Endoscopy
Zip code
Address
TEL
052-762-6111
Homepage URL
Sponsor or person
Institute
Aichi Cancer Center Hospital
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
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
| 2008 | Year | 12 | Month | 10 | 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
| 2008 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 07 | Day |
Last modified on
| 2010 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001873
