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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Promefarm S.r.l.

ClinicalTrials.gov Identifier:

NCT01509131

First received: January 4, 2012

Last updated: January 11, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2012

Last Updated Date

January 11, 2012

Start Date ^ICMJE

March 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of the quality of bowel preparation by BBPS [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01509131 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Difference in mucosal visibility between the two groups [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
Three point rating scale(0-2).
Number of patients with adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Patient questioning.
Difference in tolerability between the two groups [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation.
Difference in patients acceptability between the two groups [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Difference in the percentage of patients who took at least 75% of bowel preparation.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Colonoscopy

Intervention ^ICMJE

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 Name: Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets)
Drug: 2L PEG-ASC
Patients will asked to take PEG-ASC according to labeling instructions

Other Name: Moviprep

Study Arm (s)

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)

Intervention: Drug: 2L PEG-CS plus bisacodyl
Active Comparator: 2L PEG-ASC
Patients will be asked to take PEG-ASC according to labeling instructions

Intervention: Drug: 2L PEG-ASC

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

408

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01509131

Other Study ID Numbers ^ICMJE

PMF105BC1/09

Has Data Monitoring Committee

Responsible Party

Promefarm S.r.l.

Study Sponsor ^ICMJE

Promefarm S.r.l.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Promefarm S.r.l.

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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