![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001556 |
Receipt No. | 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 |
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 |
|
Condition | ||
Condition | colorectal disease | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
Organization | Aichi Cancer Center Hospital | ||||||
Division name | Department of Endoscopy | ||||||
Zip code | |||||||
Address | |||||||
TEL | 052-762-6111 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Aichi Cancer Center Hospital |
Institute | |
Department |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001873 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |