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

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Drug: 2L PEG-CS plus bisacodyl; Drug: 2L PEG-ASC

• Registration Number: NCT01509131
• Lead Sponsor: Promefarm S.r.l.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-11
• Last Update Submitted: 2012-01-11
• Study First Posted: 2012-01-12
• Last Update Posted: 2012-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2L PEG-CS plus bisacodyl	2L PEG-CS plus bisacodyl	Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit)
2L PEG-ASC	2L PEG-ASC	Patients will be asked to take PEG-ASC according to labeling instructions

Primary Outcome Measures

Name	Time	Method
Evaluation of the quality of bowel preparation by BBPS	20 minutes	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.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Nuovo Regina Margherita; 🇮🇹 Roma, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

IRCCS Humanitas; 🇮🇹 Rozzano, Milano, Italy

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Foggia, Italy