Trial record 2 of 6 for:    colon cleansing AND Ferring

A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy (CLEAR PREP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02386449
First received: March 6, 2015
Last updated: April 27, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Bowel Preparation
Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)
Drug: mannitol
Drug: Bisacodyl
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of subjects classified as success (Aronchick scale) [ Time Frame: At visit 2 (day 1 of colonoscopy) ] [ Designated as safety issue: No ]
    Defined as excellent or good according to the Aronchick scale


Secondary Outcome Measures:
  • Percentage of subjects classified as success (Ottawa scale) [ Time Frame: At visit 2 (day 1 of colonoscopy) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire

  • Subject satisfaction (Likert scale) [ Time Frame: At visit 2 (day 1 of colonoscopy) ] [ Designated as safety issue: No ]
    As assessed by a subject survey using a 3 point Likert scale


Estimated Enrollment: 184
Study Start Date: February 2015
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Picoprep
sodium picosulfate, magnesium oxide and citric acid
Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)
Active Comparator: Mannitol and Bisacodyl Drug: mannitol Drug: Bisacodyl

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02386449

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country) Recruiting
Sao Paulo, Brazil
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02386449     History of Changes
Other Study ID Numbers: 000180
Study First Received: March 6, 2015
Last Updated: April 27, 2015
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Bisacodyl
Citric Acid
Magnesium Oxide
Mannitol
Picosulfate sodium
Antacids
Anticoagulants
Cardiovascular Agents
Cathartics
Chelating Agents
Diuretics
Diuretics, Osmotic
Gastrointestinal Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 26, 2015