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

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Ann L. Silverman, War Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00645801
First received: March 25, 2008
Last updated: September 4, 2012
Last verified: September 2012
History of Changes

March 25, 2008
September 4, 2012
March 2008
July 2011   (final data collection date for primary outcome measure)
Amitiza® (lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo plus GoLYTELY® (polyethylene glycol-electrolyte solution) for outpatient colonoscopy preparation: A randomized, double-blind, placebo-controlled trial. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The primary objective of this study is to compare the efficacy and tolerability of Amitiza plus GoLytely to the efficacy and tolerability of a placebo plus GoLytely.
Not Provided
Complete list of historical versions of study NCT00645801 on ClinicalTrials.gov Archive Site
Amitiza® (lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo plus GoLYTELY® (polyethylene glycol-electrolyte solution) for outpatient colonoscopy preparation: A randomized, double-blind, placebo-controlled trial. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The secondary objective is to evaluate the effectiveness of a decreased volume of GoLytely in patient taking active drug compared with placebo.
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 [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Colonoscopy
  • Drug: lubiprostone (Amitiza)
    24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total
    Other Name: Amitiza
  • Drug: Placebo
    Amitiza Placebo
  • Active Comparator: 1
    Patients will receive both Amitiza and GoLYTELY
    Intervention: Drug: lubiprostone (Amitiza)
  • Placebo Comparator: 2
    Patients will receive Amitiza Placebo plus GoLYTELY
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00645801
07-024L
No
Ann L. Silverman, War Memorial Hospital
Henry Ford Health System
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Ann L Silverman, MD War Memorial Hospital
Henry Ford Health System
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP