CLEAR PREP: A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy

Sponsor

Ferring Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT02386449

Collaborator

(none)

184

Enrollment

Location

Arms

Duration (Months)

18.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation	Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®) Drug: mannitol Drug: Bisacodyl	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

184 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Picoprep sodium picosulfate, magnesium oxide and citric acid	Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)
Active Comparator: Mannitol and Bisacodyl	Drug: mannitol Drug: Bisacodyl

Arm

Intervention/Treatment

Experimental: Picoprep

sodium picosulfate, magnesium oxide and citric acid

Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)

Active Comparator: Mannitol and Bisacodyl

Drug: mannitol

Drug: Bisacodyl

Outcome Measures

Primary Outcome Measures

Percentage of subjects classified as success (Aronchick scale) [At visit 2 (day 1 of colonoscopy)]
Defined as excellent or good according to the Aronchick scale

Secondary Outcome Measures

Percentage of subjects classified as success (Ottawa scale) [At visit 2 (day 1 of colonoscopy)]
Defined as excellent, good or fair according to the Ottawa scale
Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire) [At visit 2 (day 1 of colonoscopy)]
As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire
Subject satisfaction (Likert scale) [At visit 2 (day 1 of colonoscopy)]
As assessed by a subject survey using a 3 point Likert scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men or women aged 18 to 60 years
Subjects scheduled for an elective colonoscopy
Women of child-bearing potential using at least one highly effective contraceptive method
Subjects able to understand all instructions
Informed consent signed

Exclusion Criteria:

Hypersensitivity to active ingredients
Female participants pregnant or with a positive blood pregnancy test
Acute surgical abdomen
Previous colorectal surgery
Gastrointestinal (GI) surgery
GI diseases, active inflammatory bowel disease, colon disease
Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease
Use of laxatives or antidiarrheal agents 72 hours prior to screening
Significant alterations in laboratory values or other diseases that could interfere with the results