Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep
- Conditions
- Bowel Preparation
- Interventions
- Registration Number
- NCT01073943
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 603
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PicoPrep 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. HalfLytely 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. HalfLytely bisacodyl 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist Day 2 Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as \>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as \>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist Day 2 Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? Day 2 Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? Day 2 Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation Day 2 Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was Day 2 Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? Day 2 Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? Day 2 Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Participants With Treatment-Emergent Adverse Events (TEAEs) up to one month Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.
Trial Locations
- Locations (11)
Florida Clinical Research Group
🇺🇸Clearwater, Florida, United States
Gastroenterology Research Consultants of Greater Cincinnati
🇺🇸Cincinnati, Ohio, United States
Investigational site
🇺🇸Hollywood, Florida, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
NJ Physicians, LLC
🇺🇸Passaic, New Jersey, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Gastroenterology Associates
🇺🇸Kingsport, Tennessee, United States
Vital re:Search, Inc
🇺🇸Greensboro, North Carolina, United States