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

NCT02386449 | Completed Phase 4

• 1 other identifier: 000180
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Picoprep

EXPERIMENTAL

sodium picosulfate, magnesium oxide and citric acid

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

Mannitol and Bisacodyl

ACTIVE COMPARATOR

Drug: mannitol; Drug: Bisacodyl

Interventions

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

Picoprep

mannitol DRUG

Mannitol and Bisacodyl

Bisacodyl DRUG

Mannitol and Bisacodyl

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

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

São Paulo, Brazil

Location

MeSH Terms

Interventions

picosulfate sodium; Magnesium Oxide; Citric Acid; Mannitol; Bisacodyl

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Sugar Alcohols; Alcohols; Carbohydrates; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 12, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

BR (1)