Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

Brooke Army Medical Center

Status: Completed

Conditions: Bowel Preparation for Colonoscopy

Treatments: Drug: lubiprostone; Drug: placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT00611442

IND 78254

C.2007.188

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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191 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment

Treatment:

Drug: lubiprostone

2

Placebo Comparator group

Description:

split-dose PEG solution without dietary restrictions plus placebo pretreatment

Treatment:

Drug: placebo