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
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Drug: lubiprostone (Amitiza)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 158
Study Start Date: March 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients will receive both Amitiza and GoLYTELY
Drug: lubiprostone (Amitiza)
24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total
Other Name: Amitiza
Placebo Comparator: 2
Patients will receive Amitiza Placebo plus GoLYTELY
Drug: Placebo
Amitiza Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645801

Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Henry Ford Health System
Novi, Michigan, United States, 48377
Sponsors and Collaborators
Henry Ford Health System
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Ann L Silverman, MD War Memorial Hospital
  More Information

No publications provided

Responsible Party: Ann L. Silverman, Principal Investigator, War Memorial Hospital
ClinicalTrials.gov Identifier: NCT00645801     History of Changes
Other Study ID Numbers: 07-024L
Study First Received: March 25, 2008
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Routine screening colonoscopy
Colonoscopy Preparation
Amitiza
GoLYTELY
Pegylated Electrolytes
Preparation Solution
Colonoscopy Solution

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014