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

Bowel Preparation Clinical Trial

Official title:

A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of "Day Before" PicoPrep™ for Oral Administration Versus HalfLytely® for Colon Cleansing in Preparation for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073943
• Other study ID #: 2009-02
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2010
• Last updated: October 23, 2012
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Investigative Clinical Research	Annapolis	Maryland
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Gastroenterology Research Consultants of Greater Cincinnati	Cincinnati	Ohio
United States	Florida Clinical Research Group	Clearwater	Florida
United States	Vital re:Search, Inc	Greensboro	North Carolina
United States	Investigational site	Hollywood	Florida
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Gastroenterology Associates	Kingsport	Tennessee
United States	NJ Physicians, LLC	Passaic	New Jersey
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Louisiana Research Center	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist	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. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.	Day 2	No
Primary	Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist	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.	Day 2	No
Secondary	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	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.	Day 2	No
Secondary	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?	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	Day 2	No
Secondary	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?	Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no	Day 2	No
Secondary	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation	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	Day 2	No
Secondary	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was	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	Day 2	No
Secondary	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?	Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no	Day 2	No
Secondary	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?	Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no	Day 2	No
Secondary	Participants With Treatment-Emergent Adverse Events (TEAEs)	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.	up to one month	No