Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation
Information source: Henry Ford Health System
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy
Intervention: lubiprostone (Amitiza) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Henry Ford Health System Official(s) and/or principal investigator(s):
Ann L Silverman, MD, Principal Investigator, Affiliation: Henry Ford Health System
Overall contact:
Qiana N Samuels, BA, Phone: 248-344-2357, Email: qsamuel1@hfhs.org
Summary
The primary objective is to compare the effectiveness and tolerance of Amitiza®
(lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo and
GoLYTELY ® (polyethylene glycol-electrolyte solution) as a bowel cleansing preparation for
colonoscopy.
Clinical Details
Official title: Amitiza® (Lubiprostone) Plus GoLYTELY® (Polyethylene Glycol-Electrolyte Solution) vs. Placebo Plus GoLYTELY® (Polyethylene Glycol-Electrolyte Solution) for Outpatient Colonoscopy Preparation: A Randomized, Double-Blind, Placebo-Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Secondary outcome: The secondary endpoint will be to determine if patients using Amitiza® (lubiprostone) use a smaller volume of GoLYTELY® (polyethylene glycol-electrolyte solution) compared with placebo
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is at least 18 years old
- Subject is in good health
- Subject is undergoing a screening colonoscopy
- Subject has a spontaneous bowel movement at least every 48 hours
Exclusion Criteria:
- Subject has renal insufficiency demonstrated by serum creatinine > 1. 4mg/dL
- Subject has Type 1 diabetes
- Subject has past or present diagnosis of Congestive Heart Failure
- Subject has past or present diagnosis of inflammatory bowel disease
- Subject had previous colon resection
- Subject has a preexisting electrolyte abnormality
- Subject has more than 3 spontaneous bowel movements daily
Locations and Contacts
Qiana N Samuels, BA, Phone: 248-344-2357, Email: qsamuel1@hfhs.org
Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting
Ali Nawras, MD, Phone: 313-916-5554, Email: anawras1@hfhs.org
Henry Ford Health System, Novi, Michigan 48377, United States; Recruiting
Beverly Stallings, RN, Phone: 248-344-2357, Email: bstalli1@hfhs.org
Qiana Samuels, BA, Phone: 248-344-2358, Email: qsamuel1@hfhs.org
Henry Ford Health System, West Bloomfield, Michigan 48322, United States; Recruiting
Qiana N Samuels, BA, Phone: 248-344-2357, Email: qsamuel1@hfhs.org
Additional Information
Starting date: March 2008
Last updated: March 16, 2009
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