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

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356407
• Other study ID #: FE999169 CS02
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2011
• Last updated: December 17, 2012
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: December 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• PICOPREP

• PEG-ELS

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of Successful Completion of Colonoscopy	An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)	Day 2	No
Secondary	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	No
Secondary	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	No