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

This study has been completed.
Sponsor:
Collaborators:
Virginia Mason Hospital/Medical Center
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT01650870
First received: July 23, 2012
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Colonoscopy
Drug: Crystalline Lactulose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:
  • Cleanliness of the Colon During Colonoscopy [ Time Frame: Day of the procedure ] [ Designated as safety issue: No ]

    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:
  • Treatment Failures [ Time Frame: Day of the procedure ] [ Designated as safety issue: No ]

    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).


  • Patient Tolerability and Preference [ Time Frame: Day before and day of colonoscopy ] [ Designated as safety issue: No ]
    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

  • Colonic Hydrogen and Methane Gas Production [ Time Frame: Day of colonoscopy ] [ Designated as safety issue: No ]

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

    o Colonic hydrogen and methane gas levels.


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


Enrollment: 40
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650870

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

No publications provided

Responsible Party: Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT01650870     History of Changes
Other Study ID Numbers: SplitDose Cryst. Lactulose
Study First Received: July 23, 2012
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Benaroya Research Institute:
Cathartics
Laxatives
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

Additional relevant MeSH terms:
Lactulose
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014