Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | July 2012 |
| End Date: | September 2012 |
| Contact: | Jody Mooney, MSAOM |
| Phone: | 206-341-1452 |
A Single Center, Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Split-Dose Regimen of Crystalline Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
The purpose of this study is to determine the efficacy of a split-dose regimen of
crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as
assessed by the physician's determination of the cleanliness of the colon using the Boston
Bowel Prep Scale (BBPS).
crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as
assessed by the physician's determination of the cleanliness of the colon using the Boston
Bowel Prep Scale (BBPS).
This is a single center, open-label, pilot study to determine the safety, efficacy, and
patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the
colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment
emergent adverse events. Efficacy will be determined by the endoscopist's rating of the
cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of
the bowel). Patient preference will be determined by the patient's responses on a patient
questionnaire.
patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the
colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment
emergent adverse events. Efficacy will be determined by the endoscopist's rating of the
cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of
the bowel). Patient preference will be determined by the patient's responses on a patient
questionnaire.
Inclusion Criteria:
- Patients requiring bowel evacuation for colonoscopy
Exclusion Criteria:
- Patients with galactosemia (galactose-sensitive diet)
- Patients known to be hypersensitive to any of the components of Crystalline Lactulose
- Patients with a history of a failed bowel preparation
- Patients with severe constipation, defined as those patients taking daily
prescription or over-the-counter laxatives
- Patients with possible bowel obstruction, previous colonic surgery, gastric
retention, bowel perforation, toxic colitis, toxic megacolon, or ileus
- Patients on lactulose therapy or receiving any treatment for chronic constipation
- Patients less than 18 years of age
- Inability to understand the requirements of the study or be unwilling to provide
written informed consent (as evidenced by signature on an informed consent document
approved by an Institutional Review Board [IRB]) and agree to abide by the study
restrictions
- Be pregnant or nursing
- Be otherwise unsuitable for the study, in the opinion of the Investigator
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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