Clinical trial NCT00611442: Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation for Colonoscopy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: Takeda
First posted: 2008-02-11
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
timeFrame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
Secondary outcomes:
measure: Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
timeFrame: measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)
measure: Procedure Time
timeFrame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
measure: The Number of Polyps Detected on Examination
timeFrame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Joel Z Stengel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1572-0241.2002.07129.x.
citation: Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x.
citation: 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. doi: 10.1067/mge.2003.318.
citation: 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. doi: 10.1007/BF02258217.
citation: Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. doi: 10.1097/01.mcg.0000225665.68920.df.