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

• ClinicalTrials.gov Identifier: NCT01073930
• Recruitment Status: Completed
• First Posted: February 23, 2010
• Results First Posted: September 11, 2012
• Last Update Posted: February 12, 2013
• Sponsor: Ferring Pharmaceuticals
• Information provided by (Responsible Party): Ferring Pharmaceuticals

Tracking Information

• First Submitted Date: February 22, 2010
• First Posted Date: February 23, 2010
• Results First Submitted Date: August 10, 2012
• Results First Posted Date: September 11, 2012
• Last Update Posted Date: February 12, 2013
• Study Start Date: May 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 10, 2012)

Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: February 22, 2010): To demonstrate non-inferiority of PicoPrep to HalfLytely in overall colon cleansing in preparation for colonoscopy based on the Aronchick scale [ Time Frame: Up to 2 days ]

Current Secondary Outcome Measures (submitted: August 10, 2012)

• Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist [ Time Frame: Day 2 ]
  Overall colon cleansing 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? [ Time Frame: 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? [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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) [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: February 22, 2010)

• To demonstrate non-inferiority of PicoPrep to HalfLytely with respect to the efficacy of ascending colon cleansing based on the Ottawa scale [ Time Frame: Up to 2 Days ]
• To determine tolerability and satisfaction of the preparation as assessed by a standardized subject questionnaire administered at the study site before colonoscopy [ Time Frame: Up to 2 Days ]
• To evaluate safety and tolerability through the collection of adverse events, clinical laboratory tests, and physical examination [ Time Frame: Up to 9 Days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep
• Official Title: A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of "Split-Dose" PicoPrep™ for Oral Administration Versus HalfLytely® for Colon Cleansing in Preparation for Colonoscopy
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Bowel Preparation

Intervention

• 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. The first pouch was taken between 5:00 PM and 9:00 PM the evening prior to the colonoscopy procedure. Subjects were to consume five (5) 8-ounce glasses of clear liquids over the next few hours. The second pouch was taken approximately 5 hours before but no more than 9 hours prior to the colonoscopy procedure. Subjects were to consume three (3) 8-ounce glasses of clear liquids.
  Other Names:

  • PicoPrep™
  • Prepopik™
• 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.
• Drug: bisacodyl
  Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.

Study Arms

• Experimental: PICOPREP
  "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
  Intervention: Drug: PicoPrep
• Active Comparator: 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.
  Interventions:

  • Drug: HalfLytely
  • Drug: bisacodyl

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2010): 608
• Original Estimated Enrollment (submitted: February 22, 2010): 600
• Actual Study Completion Date: October 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01073930
• Other Study ID Numbers: 2009-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ferring Pharmaceuticals
• Study Sponsor: Ferring Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Development Support; Ferring Pharmaceuticals

• PRS Account: Ferring Pharmaceuticals
• Verification Date: February 2013