Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy - Full Text View

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

ChemIDplus related topics:

Nulytely Lubiprostone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:

The cleanliness of the prep as measured by the Ottawa Scale [ Time Frame: measured upon completion of the colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient satisfaction with the prep measured by 5 point Likert scale [ Time Frame: measured after completion of the prep and prior to the colonoscopy ] [ Designated as safety issue: No ]
Procedure time [ Time Frame: measured upon completion of the colonoscopy ] [ Designated as safety issue: No ]
The number and size of polyps detected on examination [ Time Frame: measured upon completion of the colonoscopy ] [ Designated as safety issue: No ]

Enrollment:	200
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
1: Active Comparator 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
2: Placebo Comparator split-dose PEG solution without dietary restrictions plus placebo pretreatment	Drug: placebo placebo gelcap, taken at noon the day prior to the colonoscopy

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 Global Research & Development Center, Inc.

Investigators


Principal Investigator:	Joel Z Stengel, MD	Brooke Army Medical Center

More Information

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.

Responsible Party:	GI Department, Brooke Army Medical Center ( Joel Z. Stengel MD )
Study ID Numbers:	C.2007.188, IND 78254
First Received:	January 29, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00611442
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	Brooke Army Medical Center Takeda Global Research & Development Center, Inc.
Information provided by:	Brooke Army Medical Center
ClinicalTrials.gov Identifier:	NCT00611442