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

• ClinicalTrials.gov Identifier: NCT01650870
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Last Update Posted: August 8, 2014
• Sponsor: Benaroya Research Institute
• Collaborators: Virginia Mason Hospital/Medical Center; Cumberland Pharmaceuticals
• Information provided by (Responsible Party): Benaroya Research Institute

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Colonoscopy	Drug: Crystalline Lactulose	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: July 2012
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: September 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Cleanliness of the Colon During Colonoscopy [ Time Frame: Day of the procedure ]

   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.

Secondary Outcome Measures :

1. Treatment Failures [ Time Frame: Day of the procedure ]

   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).

2. Patient Tolerability and Preference [ Time Frame: Day before and day of colonoscopy ]
   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
3. Colonic Hydrogen and Methane Gas Production [ Time Frame: Day of colonoscopy ]

   To evaluate the secondary objective of measuring colonic hydrogen and methane gas production as measured by:

   o Colonic hydrogen and methane gas levels.

4. Safety/Adverse Events [ Time Frame: Day before colonoscopy till 7 days after colonoscopy ]
   To evaluate the secondary objective of safety as measured by the incidence of treatment emergent adverse events

Eligibility Criteria

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

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 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

Contacts and Locations

Locations

United States, Washington

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Sponsors and Collaborators

Benaroya Research Institute

Virginia Mason Hospital/Medical Center

Cumberland Pharmaceuticals

Investigators

• Principal Investigator: Otto Lin, MD; Virginia Mason Medical Center

More Information

• Responsible Party: Benaroya Research Institute
• ClinicalTrials.gov Identifier: NCT01650870
• Other Study ID Numbers: SplitDose Cryst. Lactulose
• First Posted: July 26, 2012
• Last Update Posted: August 8, 2014
• Last Verified: August 2014

Keywords provided by Benaroya Research Institute:

Cathartics; Laxatives; Lactulose; Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions

Additional relevant MeSH terms:

Lactulose; Gastrointestinal Agents