Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation (PEG)

May 30, 2023 updated by: Ann L. Silverman, Henry Ford Health System

Lubiprostone Plus Polyethylene Glycol-electrolyte Solutionvs. Placebo Plus 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 the medication named lubiprostone plus a large volume liquid laxative versus placebo which is a look alike medication that has no effect such as a sugar pill plus a large volume liquid laxative as a bowel cleaning preparation for colonoscopy to see the colon better during the colonoscopy to identify abnormal growths such as polyps or colon cancer.

Colonoscopy is considered the best way to screen for colon cancer screening because you can visualize the colon directly and remove or biopsy abnormal growths. The limiting step in the procedure is the quality of the colon preparation prior to the procedure. Many patients do not tolerate large volumes of liquid used to prepare the colon. The purpose of the study is to improve the quality of the prep by adding a pill laxative medication before starting the large volume laxative to better see the colon. The other aim of the study is to try to reduce the amount of of liquid laxative the patient has to drink by giving a pill laxative before starting the liquid laxative.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 colonoscopy. Patients with severe underlying medical conditions were excluded. Patients with inflammatory bowel disease, frequent bowel movements and colonic resection were also excluded. Patients were randomized to one of two groups. The study was double blinded. The first group took lubiprostone 24 micrograms and the second group took look alike placebo in 4 divided doses right before starting the bowel prep with the last dose upon starting polyethylene glycol-electrolyte solution the evening before the colonoscopy.

All study patients were educated and instructed to observe for clear stool, which was defined as "watery consistency without any solid fecal material or dark liquid stools" before stopping the liquid bowel prep. Patients were instructed to return the unused PEG solution on the day of colonoscopy. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution. This was measured on a 1-5 rating Likert scale (1) "Easy," 2) "Tolerable," 3) "Slightly Difficult," 4) "Extremely Difficult," and 5)"Unable to Finish" and was based on the patient's ability to swallow the liquid and each of 4 tablets. In addition, the pres- ence of symptoms of nausea, vomiting, abdominal pain, chest pain, dizziness, and bloating was evaluated.

The primary endpoints was the endoscopist's evaluation of the preparation quality. All colonoscopies were performed by 3 endoscopists (with 85% of the procedures performed by principal investigator of the study, A.L.S.). Endo- scopists evaluated the quality of the colonoscopy prep- aration based on the previously validated Ottawa bowel preparation scale.5 This scale rates 3 sections of colon, rectosigmoid, mid, and right colon, on a 5-point scale (0-4) and a global 3-point rating (0-2) for overall colonic fluid. The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid.The secondary endpoint was to determine any reduction in the amount of PEG consumed in the lubiprostone group compared with the placebo group.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ingested 4 tablets of lubiprostone in divided doses + 1 gallon of polyethylene glycol
First dose of lubiprostone 24 micrograms or placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were on a clear liquid diet on the day before the procedure and were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. All study patients were educated and instructed to observe for clear stool, which was defined as "watery consistency without any solid fecal material or dark liquid stools." Patients were instructed to return the unused PEG solution on the day of colonoscopy. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution.
Drug: lubiprostone (Amitiza)
24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total
Other Names:
  • Amitiza
Placebo Comparator: Ingested 4 tablets of placebo in divided doses + 1 gallon of polyethylene glycol
First dose of look alike placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were on a clear liquid diet on the day before the procedure and were instructed to initiate drinking PEG (immediately after the last dose of lubiprostone) at 6 PM the evening before the colonoscopy and continued drinking the solution until at least 2 bowel movements were clear yellow or green. All study patients were educated and instructed to observe for clear stool, which was defined as "watery consistency without any solid fecal material or dark liquid stools." Patients were instructed to return the unused PEG solution on the day of colonoscopy. After completing the preparation but before colonoscopy, patients were also required to fill a questionnaire to assess the tolerability of tablets and solution.
Drug: Placebo
Amitiza Placebo
Other Names:
  • Look alike placebo Amitiza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopist Evaluation of Colon Cleanliness in the Lubiprostone Group vs the Placebo Group
Time Frame: within 12 hours of completing bowel prep
Endoscopists evaluated the quality of the colonoscopy preparation based on Ottawa bowel preparation scale. . The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. Before using the scale for this trial, the endoscopists participated in a calibration exercise that involved 20 patients to ensure that they concurred on their interpretation of the scale.
within 12 hours of completing bowel prep

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group
Time Frame: done at the time of colonoscopy
After completing the colonoscopy prep patients were asked to assess tolerability of the prep using a 5 point Likert scale with 1 being easy and 5 being unable to complete the prep
done at the time of colonoscopy
Change in Volume of PEG From Beginning of Bowel Prep to That at Completion of the Colonoscopy Preparation in the Two Groups
Time Frame: amount of PEG at start of the study and that measured when the patient presented for their procedure.
Patients in the lubiprostone group and the placebo returned unused PEG after completing the prep for the colonoscopy. This was measured in liters and recorded.
amount of PEG at start of the study and that measured when the patient presented for their procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

Takeda Pharmaceuticals North America, Inc.

Investigators

  • Principal Investigator: Ann L Silverman, MD, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimated)

March 28, 2008

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-024L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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