Phase 3
N=608
Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep
Bowel Preparation
Bottom Line
View on ClinicalTrials.gov: NCT01073930 ↗Enrolled (actual)
608
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 — 84.2; 74.4 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 |
84.2; 74.4 | — |
| SECONDARY Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist |
89.5; 78.8; 92.4; 85.9; 92.4; 87.2 | — |
| SECONDARY Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? |
57.9; 8.1; 31.5; 20.9; 9.6; 47.0 | <0.0001 sig |
| SECONDARY Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? |
99.0; 89.9; 1.0; 10.1 | <0.0001 sig |
| SECONDARY Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation |
46.8; 16.6; 45.2; 42.9; 6.6; 28.7 | <0.0001 sig |
| SECONDARY Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was |
23.4; 2.7; 50.5; 18.9; 25.7; 56.2 | <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? |
96.0; 54.7; 4.0; 45.3 | <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? |
1.7; 13.5; 98.3; 86.5 | <0.0001 sig |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAEs) |
211; 217; 0; 0; 1; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01073930). 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.