Kristalose as Bowel Evacuant Prior to Colonoscopy

This study has been completed.
Sponsor:
Collaborators:
Virginia Mason Hospital/Medical Center
Cumberland Pharmaceuticals
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT01256541
First received: December 7, 2010
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant


Condition Intervention Phase
Bowel Evacuant Prior to Colonoscopy
Drug: Kristalose
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center, Open-Label, Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Kristalose as a Bowel Evacuant Prior to Colonoscopy

Resource links provided by NLM:


Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:
  • Hydrogen and Methane Gas Production [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    To evaluate the primary objective of hydrogen and methane gas production as measured by:

    • Pre- and post-dose breath analysis for hydrogen and methane gas.



Secondary Outcome Measures:
  • Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    To evaluate the secondary objective of efficacy, the following endpoints will be measured:

    • Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.[4]
    • 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).


Estimated Enrollment: 20
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kristalose
Kristalose as Bowel Evacuant
Drug: Kristalose
The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.

Detailed Description:

This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant prior to colonoscopy. Prior to colonoscopy, subjects will also undergo evaluation for the production of hydrogen and methane gases in the patient's gut (before and after receiving Kristalose) as assessed by a breath analysis instrument. 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).

  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:

  1. Patients with galactosemia (galactose-sensitive diet).
  2. Patients known to be hypersensitive to any of the components of Kristalose.
  3. Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
  4. Patients less than 18 years of age.
  5. 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.
  6. Be pregnant or nursing
  7. 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: NCT01256541

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
  More Information

No publications provided

Responsible Party: Otto Lin, MD, Virginia Mason Medical Center
ClinicalTrials.gov Identifier: NCT01256541     History of Changes
Other Study ID Numbers: IRB10068
Study First Received: December 7, 2010
Last Updated: October 5, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014