Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep

Completed · Phase 3

Conditions studied: Bowel Preparation

In brief

Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given a night before (first dose - sachet) and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.

Key facts

Study ID

NCT01073930

Run by

Ferring Pharmaceuticals

People needed

608

Starts

2010-05-01

Expected to finish

2010-10-01

Last updated by the study team

2013-02-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
• Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception, throughout the trial period
• Females of childbearing potential must undergo a pregnancy test at screening and again at randomization
• Subjects must have had more than or equal to 3 spontaneous bowel movements per week for one month prior to the colonoscopy
• Subjects should be willing, able and competent to complete the entire procedure and to comply with study instructions
• Written informed consent obtained prior to study

You may not qualify if…

• Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
• Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
• Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
• Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo-obstruction, hypomotility syndrome)
• Ascites
• Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
• Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
• Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
• Renal insufficiency (serum creatinine and potassium must be within normal limits)
• Participation in an investigational study within 30 days prior to receiving study medication (or within 60 days for investigational drugs with an elimination half-life greater than 15 days)
• Any clinically significant laboratory value at the screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
• Hypersensitivity to active ingredients

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Arkansas Gastroenterology — Sherwood, Arkansas, United States
• Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• Louisiana Research Center LLC — Shreveport, Louisiana, United States
• Piedmont Medical Research Associates — Winston-Salem, North Carolina, United States
• Hillmont GI, P.C. — Flourtown, Pennsylvania, United States
• ClinSearch — Chattanooga, Tennessee, United States
• Blue Ridge Medical Research — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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