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

Bowel Preparation Clinical Trial

— CLEAR PREP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386449
• Other study ID #: 000180
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2015
• Last updated: January 11, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

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

• mannitol

• Bisacodyl

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country)	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects classified as success (Aronchick scale)	Defined as excellent or good according to the Aronchick scale	At visit 2 (day 1 of colonoscopy)	No
Secondary	Percentage of subjects classified as success (Ottawa scale)	Defined as excellent, good or fair according to the Ottawa scale	At visit 2 (day 1 of colonoscopy)	No
Secondary	Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)	As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire	At visit 2 (day 1 of colonoscopy)	No
Secondary	Subject satisfaction (Likert scale)	As assessed by a subject survey using a 3 point Likert scale	At visit 2 (day 1 of colonoscopy)	No