Status:
COMPLETED
Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate
Lead Sponsor:
Promefarm S.r.l.
Conditions:
Colonoscopy
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 th...
Eligibility Criteria
Inclusion
- Out-patients undergoing a complete colonoscopy
- Patient written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT01509131
Start Date
March 1 2010
End Date
December 1 2010
Last Update
January 12 2012
Active Locations (5)
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1
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
2
IRCCS Humanitas
Rozzano, Milano, Italy, 20089
3
Spedali Civili
Brescia, Italy, 25123
4
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134