Phase 3
N=603
Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep
Bowel Preparation
Bottom Line
View on ClinicalTrials.gov: NCT01073943 ↗Enrolled (actual)
603
Serious AEs
0.5%
Results posted
Sep 2012
Primary outcome: Primary: Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist — 83.0; 79.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PicoPrep (Drug); HalfLytely (Drug); bisacodyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist |
83.0; 79.7 | — |
| 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 |
81.3; 84.0 | — |
| SECONDARY Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? |
58.4; 16.1; 29.0; 21.1; 11.6; 45.3 | <0.0001 sig |
| SECONDARY Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? |
99.7; 92.3; 0.3; 7.7 | <0.0001 sig |
| SECONDARY Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation |
45.5; 19.1; 43.8; 48.7; 9.2; 25.5 | <0.0001 sig |
| SECONDARY Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was |
25.6; 4.0; 48.1; 23.8; 23.9; 52.3 | <0.0001 sig |
| 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? |
93.2; 59.4; 6.8; 40.6 | <0.0001 sig |
| 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? |
4.8; 14.4; 95.2; 85.6 | <0.0001 sig |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAEs) |
218; 241; 0; 0; 2; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01073943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.