2 Regimens of Lactulose for Colonoscopy Preparation in Adults
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | July 2013 |
End Date: | October 2013 |
Contact: | Amy Rock, PhD |
Email: | arock@cumberlandpharma.com |
Phone: | 615.255.0068 |
A Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of 2 Regimens of Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a
preparation for colonoscopy.
preparation for colonoscopy.
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 lactulose for oral
solution.
- Patients with an abnormality on screening blood work or vital sign assessments that,
in the Investigator's judgment, may pose a significant risk including those
pertaining to dehydration or electrolyte shifts.
- Patients with a history of impaired renal function.
- Patients with current or recent history of hypotension, as defined by the
Investigator.
- Patients with a history of long Q-T syndrome.
- 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, gastric retention, bowel perforation, toxic
colitis, toxic megacolon, ileus or previous colonic surgery.
- Patients on lactulose therapy or receiving any treatment for chronic constipation.
- Be pregnant or nursing.
- Patients with known large polyps or flat polyps (i.e. polyps requiring electrocautery
or argon plasma coagulation).
- 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 otherwise unsuitable for the study, in the opinion of the Investigator.
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