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
Overview
- Phase
- Phase 2
- Intervention
- Full dose preparation
- Conditions
- Colonoscopy Preparation
- Sponsor
- Cumberland Pharmaceuticals
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Efficacy of Lactulose as a Preparation for Colonoscopy.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.
Detailed Description
A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose regimen, where three doses are taken on the prior evening, and one dose is taken the morning of the procedure.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Full dose preparation; AM colonoscopy
Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day.
Intervention: Full dose preparation
Full dose preparation; PM colonoscopy
Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day.
Intervention: Full dose preparation
Split dose preparation; AM colonoscopy
Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
Intervention: Split dose preparation
Split dose preparation; PM colonoscopy
Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
Intervention: Split dose preparation
Outcomes
Primary Outcomes
Efficacy of Lactulose as a Preparation for Colonoscopy.
Time Frame: at least 3 hours post last consumption
Efficacy assessed by the physician's determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue. The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility.
Secondary Outcomes
- Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3(3 - 15 hours post last consumption)
- Colonic Methane Gas Levels(3 - 15 hours post last consumption)
- Incidence of Treatment Failure(at least 3 hours post last consumption)
- Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1(3-15 hours post last consumption)
- Colonic Hydrogen Gas Levels(3 - 15 hours post last consumption)
- Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)(3 - 15 hours post last consumption)
- Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2(3-15 hours post last consumption)
- Tolerability of and Preference for Lactulose as a Bowel Evacuant(3 to 15 hours post last consumption)