Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: Lubiprostone; Pharmaceutical Solutions; Polyethylene glycol 3350

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