Status:
COMPLETED
Kristalose as Bowel Evacuant Prior to Colonoscopy
Lead Sponsor:
Benaroya Research Institute
Collaborating Sponsors:
Virginia Mason Hospital/Medical Center
Cumberland Pharmaceuticals
Conditions:
Bowel Evacuant Prior to Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient pref...
Detailed Description
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant prior to colonoscopy. Prior to colonoscopy, subjects will a...
Eligibility Criteria
Inclusion
- Patients requiring bowel evacuation for colonoscopy
Exclusion
- Patients with galactosemia (galactose-sensitive diet).
- Patients known to be hypersensitive to any of the components of Kristalose.
- Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01256541
Start Date
December 1 2010
End Date
September 1 2011
Last Update
October 6 2011
Active Locations (1)
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1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101