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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356407
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: PICOPREP Drug: PEG-ELS Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2011
Primary Completion Date : May 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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.
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.

Primary Outcome Measures :
  1. The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation [ Time Frame: 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 :
  1. Patient Response to Acceptability and Tolerability Questionnaire [ Time Frame: 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)).

  2. Ottawa Scale Score by Colon Segment [ Time Frame: 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

  3. Percentage of Successful Completion of Colonoscopy [ Time Frame: Day 2 ]
    An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)

  4. Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) [ Time Frame: 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

  5. Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation [ Time Frame: Day 2 ]
    The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356407

Nanfang Hospital, Southern Medical University
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Drum Tower Hospital
Nanjing, China
Changhai Hospital, The Second Military Medical University
Shanghai, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Huazhong Technological University Tongji Medical College Affiliated Union Hospital
Wuhan, China
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01356407     History of Changes
Other Study ID Numbers: FE999169 CS02
First Posted: May 19, 2011    Key Record Dates
Results First Posted: January 28, 2013
Last Update Posted: January 28, 2013
Last Verified: December 2012

Additional relevant MeSH terms:
Picosulfate sodium
Gastrointestinal Agents