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

Ferring

Status and phase: Completed; Phase 3

Conditions: Colonoscopy

Treatments: Drug: PEG-ELS; Drug: PICOPREP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01356407

FE999169 CS02

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

PICOPREP

Experimental group

Description:

"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.

Treatment:

Drug: PICOPREP

PEG-ELS

Active Comparator group

Description:

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.

Treatment:

Drug: PEG-ELS