Phase 3
N=300
Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT01356407 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation — 4.73; 4.91 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PICOPREP (Drug); PEG-ELS (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation |
4.73; 4.91 | — |
| SECONDARY Patient Response to Acceptability and Tolerability Questionnaire |
1.31; 1.45; 1.13; 1.12; 1.22; 1.64 | — |
| SECONDARY Ottawa Scale Score by Colon Segment |
1.56; 1.73; 1.43; 1.33; 1.25; 1.23 | — |
| SECONDARY Percentage of Successful Completion of Colonoscopy |
0; 0; 100; 100 | — |
| SECONDARY Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) |
4.54; 4.63; 10.00; 9.22 | — |
| SECONDARY Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation |
139; 137; 5; 9 | — |
Summary
Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.
Eligibility Criteria
Inclusion Criteria
- Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
- Chinese citizen
- Males or females aged between 18 and 70 years inclusive
- Patients scheduled for colonoscopy
- Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure
Exclusion Criteria
- Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control
- Taking concomitant lithium
- Allergy to any ingredient in the study medication
- History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction)
- Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening
- Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
- Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation, diverticulitis or appendicitis)
- Ascites
- History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding, gastric bypass surgery)
- History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic surgery)
- Uncontrolled angina and/or myocardial infarction, congestive heart failure, or uncontrolled hypertension within 3 months prior randomisation
- Severe liver damage
- Kidney function impairment
- Diabetics currently on insulin treatment
- Having participated in any other clinical trial during the 3 month prior recruitment
- Patients who are unable to act in a legal capacity, unable to meet or perform study requirements
Data sourced from ClinicalTrials.gov (NCT01356407). 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.