Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy

A Multi-center, Randomized, Single-blind Clinical Study of the Efficacy and Safety of PICOPREP and Polyethylene Glycol-electrolyte 4000 Powder for Oral Solution (PEG-ELS) for the Bowel Preparation Prior Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: PICOPREP; Drug: PEG-ELS

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Nanfang Hospital, Southern Medical University
  • Guangzhou, China
    • The First Affiliated Hospital, Sun Yat-sen University
  • Nanjing, China
    • Drum Tower Hospital
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
  • Shanghai, China
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • ChangHai Hospital, The Second Military Medical University
  • Wuhan, China
    • Huazhong Technological University Tongji Medical College Affiliated Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: PICOPREP
Active Comparator: 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.	Drug: PEG-ELS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation	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)	day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Response to Acceptability and Tolerability Questionnaire	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)).	Day 2
Ottawa Scale Score by Colon Segment	Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score	Day 2
Percentage of Successful Completion of Colonoscopy	An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)	Day 2
Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)	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	Day 2
Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation	The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation	Day 2

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Estimate): January 28, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Picosulfate sodium
• Other Study ID Numbers: FE999169 CS02