Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep

NCT ID: NCT01073943

Last Updated: 2012-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 603 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-10-31

Brief Summary

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.

Conditions

Bowel Preparation

Keywords

Bowel Preparation; Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PicoPrep

"Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy.

Group Type: EXPERIMENTAL

PicoPrep

Intervention Type: DRUG

PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy.

HalfLytely

HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Group Type: ACTIVE_COMPARATOR

bisacodyl

Intervention Type: DRUG

Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.

HalfLytely

Intervention Type: DRUG

HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.

Interventions

bisacodyl

Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.

Intervention Type: DRUG

PicoPrep

PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy.

Intervention Type: DRUG

HalfLytely

HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.

Intervention Type: DRUG

Other Intervention Names

PicoPrep™; Prepopik™

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Countries

United States

Other Identifiers

2009-02

Identifier Type: -

Identifier Source: org_study_id