Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy
Information source: Brooke Army Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bowel Preparation for Colonoscopy
Intervention: lubiprostone (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Brooke Army Medical Center Official(s) and/or principal investigator(s):
Joel Z Stengel, MD, Principal Investigator, Affiliation: Brooke Army Medical Center
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The cleanliness of the prep as measured by the Ottawa Scale
Secondary outcome: Patient satisfaction with the prep measured by 5 point Likert scaleProcedure time The number and size of polyps detected on examination
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States
Additional Information
Related publications: Harewood GC, Wiersema MJ, Melton LJ 3rd. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002 Dec;97(12):3186-94. Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. Review. El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. Church JM. Effectiveness of polyethylene glycol antegrade gut lavage bowel preparation for colonoscopy--timing is the key! Dis Colon Rectum. 1998 Oct;41(10):1223-5. Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. Review.
Starting date: October 2007
Ending date: January 2008
Last updated: January 29, 2008
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