Overview

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

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ferring Pharmaceuticals
Treatments:
Bisacodyl
Picosulfate sodium
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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