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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
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Drug: 2L PEG-CS plus bisacodyl
Drug: 2L PEG-ASC
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC

Resource links provided by NLM:


Further study details as provided by Promefarm S.r.l.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 408
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Moviprep

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509131

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

No publications provided

Responsible Party: Promefarm S.r.l.
ClinicalTrials.gov Identifier: NCT01509131     History of Changes
Other Study ID Numbers: PMF105BC1/09
Study First Received: January 4, 2012
Last Updated: January 11, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014