Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation

Completed · Phase 4 · Has a placebo group

Conditions studied: Colonoscopy

In brief

The primary objective is to compare the effectiveness and tolerance of the medication named lubiprostone plus a large volume liquid laxative versus placebo which is a look alike medication that has no effect such as a sugar pill plus a large volume liquid laxative as a bowel cleaning preparation for colonoscopy to see the colon better during the colonoscopy to identify abnormal growths such as polyps or colon cancer. Colonoscopy is considered the best way to screen for colon cancer screening because you can visualize the colon directly and remove or biopsy abnormal growths. The limiting step in the procedure is the quality of the colon preparation prior to the procedure. Many patients do not tolerate large volumes of liquid used to prepare the colon. The purpose of the study is to improve the quality of the prep by adding a pill laxative medication before starting the large volume laxative to better see the colon. The other aim of the study is to try to reduce the amount of of liquid laxative the patient has to drink by giving a pill laxative before starting the liquid laxative.

Key facts

Study ID

NCT00645801

Run by

Henry Ford Health System

People needed

158

Starts

2008-03-01

Expected to finish

2011-07-01

Last updated by the study team

2023-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is at least 18 years old
• Subject is in good health
• Subject is undergoing a screening, surveillance or diagnostic colonoscopy
• Subject has a spontaneous bowel movement at least every 48 hours

You may not qualify if…

• 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

Where it is running

• Henry Ford Hospital — Detroit, Michigan, United States
• Henry Ford Health System — Novi, Michigan, United States
• Henry Ford Health System — West Bloomfield, Michigan, United States

Full record on ClinicalTrials.gov

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