Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults

A Single Center, Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Split-Dose Regimen of Crystalline Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults

The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Crystalline Lactulose

Detailed Description

This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel). Patient preference will be determined by the patient's responses on a patient questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Crystalline Lactulose
• 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, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus
• Patients on lactulose therapy or receiving any treatment for chronic constipation
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Evening Only (full-dose); The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.	Drug: Crystalline Lactulose
Experimental: Split-dose; The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure.	Drug: Crystalline Lactulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cleanliness of the Colon During Colonoscopy	To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured: o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.	Day of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Failures	To evaluate the secondary objective of efficacy, the following endpoint will be measured: o The number and percentage of patient's who by the physician's determination are considered treatment failures (patients with insufficient evacuation of the bowel=Boston bowel prep score < 5, and/or any colon segment score of 0).	Day of the procedure
Patient Tolerability and Preference	To evaluate the secondary objective of patient tolerability and preference on the basis of the following assessments: Patient tolerability and preference questionnaire including 100 mm Visual Analog Scale (VAS) and Likert Scale	Day before and day of colonoscopy
Colonic Hydrogen and Methane Gas Production	To evaluate the secondary objective of measuring colonic hydrogen and methane gas production as measured by: o Colonic hydrogen and methane gas levels.	Day of colonoscopy
Safety/Adverse Events	To evaluate the secondary objective of safety as measured by the incidence of treatment emergent adverse events	Day before colonoscopy till 7 days after colonoscopy

Collaborators and Investigators

• Sponsor: Benaroya Research Institute
• Collaborators: Cumberland Pharmaceuticals; Virginia Mason Hospital/Medical Center
• Investigators: Principal Investigator: Otto Lin, MD, Virginia Mason Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 7, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacologic Actions; Therapeutic Uses; Gastrointestinal Agents; Lactulose; Cathartics; Laxatives
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: SplitDose Cryst. Lactulose