Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before 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 in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure 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

NCT01073943

Run by

Ferring Pharmaceuticals

People needed

603

Starts

2010-05-01

Expected to finish

2010-10-01

Last updated by the study team

2012-10-30

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

• Florida Clinical Research Group — Clearwater, Florida, United States
• Investigational site — Hollywood, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Louisiana Research Center — Shreveport, Louisiana, United States
• Investigative Clinical Research — Annapolis, Maryland, United States
• NJ Physicians, LLC — Passaic, New Jersey, United States
• Vital re:Search, Inc — Greensboro, North Carolina, United States
• Gastroenterology Research Consultants of Greater Cincinnati — Cincinnati, Ohio, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Gastroenterology Associates — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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