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Completed

NCT Number: NCT02386449

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

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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Key information

Conditions

Bowel Preparation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Mannitol

Drug

Bisacodyl

Drug

Primary outcomes

  1. Percentage of subjects classified as success (Aronchick scale)

    Time frame: At visit 2 (day 1 of colonoscopy)

    Defined as excellent or good according to the Aronchick scale

Secondary outcomes

  1. Percentage of subjects classified as success (Ottawa scale)

    Time frame: At visit 2 (day 1 of colonoscopy)

    Defined as excellent, good or fair according to the Ottawa scale

  2. Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)

    Time frame: At visit 2 (day 1 of colonoscopy)

    As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire

  3. Subject satisfaction (Likert scale)

    Time frame: At visit 2 (day 1 of colonoscopy)

    As assessed by a subject survey using a 3 point Likert scale

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: CLEAR PREP

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2015
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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