Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy

• 90 grams of Crystalline Lactulose (Drug): 15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
• 135 grams of Crystalline Lactulose (Drug): 15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
• 180 grams of Crystalline Lactulose (Drug): 15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses

Primary outcomes

• Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. [10-14 hours post last consumption]: Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.

Secondary outcomes

• Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence [1 day post last consumption]: Safety determined by the incidence of treatment emergent adverse events.
• Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity [1 day post last consumption]: Safety determined by the severity of treatment emergent adverse events.
• Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant [1 day post last consumption]: Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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 a known abnormality on screening or a 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 (except hemorrhoidectomy and polypectomy).
* Patients on lactulose therapy or receiving any treatment for chronic constipation.
* Be pregnant or nursing.
* Patients expected to require 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.

Participant flow

Outcome results

• Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. (Primary), Mean, units on a scale: 90 Grams of Crystalline Lactulose 5.7 +/- 2.8; 135 Grams of Crystalline Lactulose 7.4 +/- 0.9; 180 Grams of Crystalline Lactulose 7.8 +/- 0.8
• Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence (Secondary), Number, % of patients with adverse events: 90 Grams of Crystalline Lactulose 25; 135 Grams of Crystalline Lactulose 33; 180 Grams of Crystalline Lactulose 50
• Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity (Secondary), Number, Percentage of subjects: 90 Grams of Crystalline Lactulose 0; 135 Grams of Crystalline Lactulose 25; 180 Grams of Crystalline Lactulose 50
• Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant (Secondary), Mean, units on a VAS scale: 90 Grams of Crystalline Lactulose 65.4 +/- 27.6; 135 Grams of Crystalline Lactulose 68.5 +/- 19.6; 180 Grams of Crystalline Lactulose 71.3 +/- 18.4

Adverse events

Time frame: Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).

Other adverse events by term

• Richard Krause, MD, Principal investigator, ClinSearch, LLC