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

NCT02386449 — Phase 4, Completed, 184 participants, Ferring Pharmaceuticals

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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

Registry	NCT02386449, acronym CLEAR PREP
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single
Enrollment	184 (Actual)
Sponsor	Ferring Pharmaceuticals (Industry)
Conditions	Bowel Preparation
Interventions	sodium picosulfate, magnesium oxide and citric acid (Picoprep®), mannitol, Bisacodyl (Drug)
Dates	start 2015-02-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2015-03-12, last updated 2016-01-12
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Picoprep	Experimental	Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)	sodium picosulfate, magnesium oxide and citric acid
Mannitol and Bisacodyl	Active comparator	Drug: mannitol; Drug: Bisacodyl

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

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: 18 Years to 60 Years

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

+Locations (1)

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

+Investigators

Clinical Development Support, Study director, Ferring Pharmaceuticals