Clinical trial NCT01073930: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation
Keywords: Bowel Preparation
Colonoscopy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
timeFrame: Day 2
Secondary outcomes:
measure: Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
timeFrame: Day 2
measure: Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
timeFrame: Day 2
measure: Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
timeFrame: Day 2
measure: Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
timeFrame: Day 2
measure: Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
timeFrame: Day 2
measure: 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?
timeFrame: Day 2
measure: 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?
timeFrame: Day 2
measure: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: up to one month
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Sherwood
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Bristol
country: United States
facility: Connecticut Gastroenterology Institute
state: Connecticut
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Shreveport
country: United States
facility: Louisiana Research Center LLC
state: Louisiana
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Flourtown
country: United States
facility: Hillmont GI, P.C.
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: