UMIN ID: UMIN000001556
Registered date:10/12/2008
The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | colorectal disease |
| Date of first enrollment | 2009/01/01 |
| Target sample size | 400 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Niflec 2000ml with Gasmotin 15mg Niflec 2000ml with placebo Niflec 1500ml with Gasmotin 15mg |
Outcome(s)
| Primary Outcome | tolerability of bowel preparation with polyethylene glycol electrolyte lavage |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Aichi Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 052-762-6111 |
| Affiliation | Aichi Cancer Center Hospital Department of Endoscopy |
| scientific contact | |
| Name | Masahiro Tajika |
| Address | 1-1 Kanokoden, Chikusa-ku, Nagoya City, 464-8681, Japan Japan |
| Telephone | |
| Affiliation | Aichi Cancer Center Hospital Department of Endoscopy |