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

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

Sponsors

Lead Sponsor: Ferring Pharmaceuticals

Source Ferring Pharmaceuticals
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.

Overall Status Completed
Start Date 2015-02-01
Completion Date 2015-12-01
Primary Completion Date 2015-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of subjects classified as success (Aronchick scale) At visit 2 (day 1 of colonoscopy)
Secondary Outcome
Measure Time Frame
Percentage of subjects classified as success (Ottawa scale) At visit 2 (day 1 of colonoscopy)
Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire) At visit 2 (day 1 of colonoscopy)
Subject satisfaction (Likert scale) At visit 2 (day 1 of colonoscopy)
Enrollment 184
Condition
Intervention

Intervention Type: Drug

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

Arm Group Label: Picoprep

Intervention Type: Drug

Intervention Name: mannitol

Arm Group Label: Mannitol and Bisacodyl

Intervention Type: Drug

Intervention Name: Bisacodyl

Arm Group Label: Mannitol and Bisacodyl

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Clinical Development Support Study Director Ferring Pharmaceuticals
Location
Facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country)
Location Countries

Brazil

Verification Date

2016-01-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Picoprep

Type: Experimental

Description: sodium picosulfate, magnesium oxide and citric acid

Label: Mannitol and Bisacodyl

Type: Active Comparator

Acronym CLEAR PREP
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

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