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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2015

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Picoprep
    • sodium picosulfate, magnesium oxide and citric acid
  • Active Comparator: Mannitol and Bisacodyl

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ferring Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Development Support, Study Director, Ferring Pharmaceuticals

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