NCT01509131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

January 4, 2012

Last Update Submit

January 11, 2012

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Difference in mucosal visibility between the two groups

    20 minutes

  • Number of patients with adverse events

    24 hours

  • Difference in tolerability between the two groups

    24 hours

  • Difference in patients acceptability between the two groups

    24 hours

  • Difference in patients compliance between the two groups

    24 hours

Study Arms (2)

2L PEG-CS plus bisacodyl

EXPERIMENTAL

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

2L PEG-ASC

ACTIVE COMPARATOR

Patients will be asked to take PEG-ASC according to labeling instructions

Drug: 2L PEG-ASC

Interventions

2L PEG-CS plus bisacodylDRUG

Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)

Also known as: Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets)
2L PEG-CS plus bisacodyl
2L PEG-ASCDRUG

Patients will asked to take PEG-ASC according to labeling instructions

Also known as: Moviprep
2L PEG-ASC

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

IRCCS Humanitas

Rozzano, Milano, 20089, Italy

Location

Spedali Civili

Brescia, 25123, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

Location

Nuovo Regina Margherita

Roma, 00185, Italy

Location

MeSH Terms

Interventions

BisacodylMoviPrep

Intervention Hierarchy (Ancestors)

CresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 12, 2012

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

IT(5)