Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Joel Z. Stengel, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00611442
First received: January 29, 2008
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.


Condition Intervention
Bowel Preparation for Colonoscopy
Drug: lubiprostone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Single Dose Lubiprostone Along With Split-dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy, a Randomized, Double-blind, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • The Overall Cleanliness of the Prep as Measured by the Ottawa Scale [ Time Frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) ] [ Designated as safety issue: No ]
    Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid


Secondary Outcome Measures:
  • Patient Satisfaction With the Prep Measured by 5 Point Likert Scale [ Time Frame: measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period) ] [ Designated as safety issue: No ]
    The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.

  • Procedure Time [ Time Frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) ] [ Designated as safety issue: No ]
    Procedure time refers to the total length of time required to complete the colonoscopy

  • The Number of Polyps Detected on Examination [ Time Frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) ] [ Designated as safety issue: No ]
    The number of colon polyps detected during the colonoscopy.


Enrollment: 191
Study Start Date: October 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
Drug: lubiprostone
lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy
Other Name: amitiza
Placebo Comparator: 2
split-dose PEG solution without dietary restrictions plus placebo pretreatment
Drug: placebo
placebo gelcap, taken at noon the day prior to the colonoscopy
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
  • Ages will be from 18 years of age and older

Exclusion Criteria:

  • Chronic kidney disease
  • Previous diagnosis of congestive heart failure
  • History of bowel obstruction
  • History of solid organ transplant
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611442

Locations
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
Takeda
Investigators
Principal Investigator: Joel Z Stengel, MD Brooke Army Medical Center