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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PICOPREP

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

PEG-ELS

Intervention Type DRUG

Interventions

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PICOPREP

Intervention Type DRUG

PEG-ELS

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No