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