Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation
Condition: Colonoscopy
Intervention: lubiprostone (Amitiza); Placebo
Intervention description: 24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total; Amitiza Placebo
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blinding was done to ensure minimum bias. The clinicians attending to the patients were not involved in the randomization process, and all were blinded to the identity of the drug received as the placebo was identical to the active drug in packaging, appearance, and schedule of administration. Separate individuals generated the allocation sequence, enrolled participants, and assigned participants to their groups. The blind was maintained until all decisions regarding data evaluability were made. Only the research assistant who assigned participants to their treatment groups was permitted access to the randomization list, which was maintained in a locked filing cabinet during the trial. The patients were blinded to their medication status.
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Routine screening colonoscopy; Colonoscopy Preparation; Amitiza; GoLYTELY; Pegylated Electrolytes; Preparation Solution; Colonoscopy Solution

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 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.
    

Eligibility criteria:

        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