Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC

It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: 2L PEG-CS plus bisacodyl; Drug: 2L PEG-ASC

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25123
    • Spedali Civili
  • Firenze, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi
  • Roma, Italy, 00185
    • Nuovo Regina Margherita
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Milano
    • Rozzano, Milano, Italy, 20089
      • IRCCS Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Out-patients undergoing a complete colonoscopy
• Patient written informed consent

Exclusion Criteria:

• Pregnant or lactating women or at a risk of becoming pregnant
• Hypersensitivity to any of the ingredients
• History of anaphylaxis to drugs or allergic reactions in general
• Known or suspected gastrointestinal obstruction or perforation
• Toxic megacolon; major colonic resection
• Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study
• Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency
• Unwillingness to co-operate and to comply with the requirements of the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2L PEG-CS plus bisacodyl; Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit)	Drug: 2L PEG-CS plus bisacodyl; Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit); Other Names: Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets)
ACTIVE_COMPARATOR: 2L PEG-ASC; Patients will be asked to take PEG-ASC according to labeling instructions	Drug: 2L PEG-ASC; Patients will asked to take PEG-ASC according to labeling instructions; Other Names: Moviprep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the quality of bowel preparation by BBPS	BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mucosal visibility between the two groups	Three point rating scale(0-2).	20 minutes
Number of patients with adverse events	Patient questioning.	24 hours
Difference in tolerability between the two groups	Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation.	24 hours
Difference in patients acceptability between the two groups	Difference in the percentage of patients in the two groups who were willing to repeat the preparation and easy to take the bowel preparation.	24 hours
Difference in patients compliance between the two groups	Difference in the percentage of patients who took at least 75% of bowel preparation.	24 hours

Collaborators and Investigators

• Sponsor: Promefarm S.r.l.
• Investigators: Principal Investigator: Alessandro Repici, MD, IRCSS Istituto Clinico Humanitas, Rozzano (MI) - Italy; Principal Investigator: Renzo Cestari, Prof. MD, Spedali Civili di Brescia, Brescia - Italy; Principal Investigator: Cesare Hassan, MD, Nuovo Regina Margherita, Roma - Italy; Principal Investigator: Angelo Andriulli, MD, IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo - Italy; Principal Investigator: Vito Annese, MD, Ospedale Careggi, Firenze - Italy

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (ESTIMATE): January 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 12, 2012
• Last Update Submitted That Met QC Criteria: January 11, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: PMF105BC1/09