Clinical trial NCT01356407: Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation
timeFrame: day 2
Secondary outcomes:
measure: Patient Response to Acceptability and Tolerability Questionnaire
timeFrame: Day 2
measure: Ottawa Scale Score by Colon Segment
timeFrame: Day 2
measure: Percentage of Successful Completion of Colonoscopy
timeFrame: Day 2
measure: Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)
timeFrame: Day 2
measure: Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation
timeFrame: Day 2
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Nanjing
country: China
facility: Drum Tower Hospital
city: Shanghai
country: China
facility: Changhai Hospital, The Second Military Medical University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
city: Wuhan
country: China
facility: Huazhong Technological University Tongji Medical College Affiliated Union Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: