Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate
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|ClinicalTrials.gov Identifier: NCT01509131|
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : January 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Drug: 2L PEG-CS plus bisacodyl Drug: 2L PEG-ASC||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||408 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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
- Evaluation of the quality of bowel preparation by BBPS [ Time Frame: 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.
- Difference in mucosal visibility between the two groups [ Time Frame: 20 minutes ]Three point rating scale(0-2).
- Number of patients with adverse events [ Time Frame: 24 hours ]Patient questioning.
- Difference in tolerability between the two groups [ Time Frame: 24 hours ]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 ]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 ]Difference in the percentage of patients who took at least 75% of bowel preparation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509131
|IRCCS Ospedale Casa Sollievo della Sofferenza|
|San Giovanni Rotondo, Foggia, Italy, 71013|
|Rozzano, Milano, Italy, 20089|
|Brescia, Italy, 25123|
|Azienda Ospedaliero Universitaria Careggi|
|Firenze, Italy, 50134|
|Nuovo Regina Margherita|
|Roma, Italy, 00185|
|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|