Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose PEG

NCT02070341 | Terminated Phase 4 DMC

• 1 other identifier: Hookey Picosalax PEG
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation administration is now recognized as an important component for achieving superior cleansing. Multiple randomized controlled trials and meta-analyses have found split-dosing to be superior than day-before dosing. Objective: This study aims to compare two types of bowel preparations in split-doses to assess for differences in patient tolerability, as well as efficacy of colon cleansing. Methods: This is a prospective, single-blinded, randomized-controlled trial. Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will be randomly assigned to receive either a split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient tolerability will be examined through questionnaires. The endoscopist performing the colonoscopy will use two standardized bowel preparation scoring systems to evaluate the quality of the cleansing. The investigators propose that P/MC will be superior to PEG in patient tolerability and non-inferior in bowel cleansing effects.

Conditions

Bowel Preparation

Keywords

patient tolerability; quality

Outcome Measures

Primary Outcomes (1)

• Patient tolerability

  Patients will be asked to complete a questionnaire to assess ease of completion and symptoms. Questionnaire items are weighted on a 5-point Likert scale. Interference with sleep will be assessed through a questionnaire that is based on a modified validated sleep questionnaire (St. Mary's Hospital Sleep Questionnaire). Participants will be asked to complete this questionnaire at the initial appointment and again on the day of their procedure

  Two days

Secondary Outcomes (1)

• Quality of bowel preparation

  During colonoscopy

Study Arms (2)

Split dose PEG

EXPERIMENTAL

Patients randomized to the Polyethylene Glycol (PEG) group will be instructed to ingest 2L of bowel preparation the night before their colonoscopy (starting at 7PM), as well as 1.5-2L of carbohydrate-electrolyte rehydration solution. The following day they will be instructed to ingest the remaining 2L of bowel preparation and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy.

Drug: Polyethylene Glycol

Split dose Picosalax

EXPERIMENTAL

Patients randomized to the Picosalax (P/MC) group will be instructed to mix one sachet in 150mL of water and ingest the entire mixture at 7PM the night before their colonoscopy. In addition, they will be instructed to ingest 1.5-2L of carbohydrate-electrolyte rehydration solution after they consume the P/MC sachet. The following day they will mix the second sachet in 150mL of water and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy. They will also be instructed to drink additional carbohydrate-electrolyte rehydration solution after they ingest the P/MC sachet.

Drug: Picosalax

Interventions

Polyethylene Glycol DRUG

Split dose PEG

Picosalax DRUG

Split dose Picosalax

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All male and non-pregnant female patients between ages 18 and 75 years old who require outpatient colonoscopy

You may not qualify if:

• ileus or bowel obstruction, previous colorectal surgery, ascites, recognized renal impairment, defined as GFR less than normal in 3 months prior to enrollment, active inflammatory bowel disease, insulin dependent diabetes, pregnancy, or recent (\<6 months) myocardial infarction or unstable angina

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L5G2, Canada

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Lawrence Hookey

  Queen's University

  PRINCIPAL INVESTIGATOR

• Stephen Vanner

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

CA (1)