Status:
COMPLETED
Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
The study is a double blind placebo controlled study of lubiprostone in 4 doses vs look alike placebo in 4 doses before bowel preparation for outpatient screening, surveillance and diagnostic colonosc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00645801
Start Date
March 1 2008
End Date
July 1 2011
Last Update
June 1 2023
Active Locations (3)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Henry Ford Health System
Novi, Michigan, United States, 48377
3
Henry Ford Health System
West Bloomfield, Michigan, United States, 48322