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

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650870
• Other study ID #: SplitDose Cryst. Lactulose
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2012
• Last updated: August 7, 2014
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: August 2014
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Crystalline Lactulose

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Benaroya Research Institute	Cumberland Pharmaceuticals, Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes