2 Regimens of Lactulose for Colonoscopy Preparation in Adults

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Colonoscopy Preparation

Treatments: Drug: Full dose preparation; Drug: Split dose preparation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01887470

CPI-KR-004

Details and patient eligibility

About

The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 4 patient groups

Full dose preparation; AM colonoscopy

Experimental group

Description:

Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day.

Treatment:

Drug: Full dose preparation

Full dose preparation; PM colonoscopy

Experimental group

Description:

Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day.

Treatment:

Drug: Full dose preparation

Split dose preparation; AM colonoscopy

Experimental group

Description:

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.

Treatment:

Drug: Split dose preparation

Split dose preparation; PM colonoscopy

Experimental group

Description:

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.

Treatment:

Drug: Split dose preparation