Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy
- Registration Number
- NCT01356407
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-ELS PEG-ELS PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination. PICOPREP PICOPREP "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
- Primary Outcome Measures
Name Time Method The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation day 2 The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)
- Secondary Outcome Measures
Name Time Method Patient Response to Acceptability and Tolerability Questionnaire Day 2 On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).
Ottawa Scale Score by Colon Segment Day 2 Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score
Percentage of Successful Completion of Colonoscopy Day 2 An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)
Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) Day 2 At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality "adequate for clinical diagnostic purposes" (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes
Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation Day 2 The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation
Trial Locations
- Locations (7)
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Changhai Hospital, The Second Military Medical University
🇨🇳Shanghai, China
Drum Tower Hospital
🇨🇳Nanjing, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Huazhong Technological University Tongji Medical College Affiliated Union Hospital
🇨🇳Wuhan, China