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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509131
• Other study ID #: PMF105BC1/09
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2012
• Last updated: January 11, 2012
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Promefarm S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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)
• 2L PEG-ASC
Patients will asked to take PEG-ASC according to labeling instructions

Locations

Country	Name	City	State
Italy	Spedali Civili	Brescia
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze
Italy	Nuovo Regina Margherita	Roma
Italy	IRCCS Humanitas	Rozzano	Milano
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia

Sponsors (1)

Lead Sponsor	Collaborator
Promefarm S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Difference in mucosal visibility between the two groups	Three point rating scale(0-2).	20 minutes	No
Secondary	Number of patients with adverse events	Patient questioning.	24 hours	Yes
Secondary	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	No
Secondary	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	No
Secondary	Difference in patients compliance between the two groups	Difference in the percentage of patients who took at least 75% of bowel preparation.	24 hours	No