A Phase 4 interventional study of sodium picosulfate, magnesium oxide and citric acid (Picoprep®) and mannitol in Bowel Preparation, sponsored by Ferring Pharmaceuticals. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-01-12.
Sponsored by Ferring Pharmaceuticals · Phase 4 and Interventional
This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.
Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
sodium picosulfate, magnesium oxide and citric acid
Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)
Drug: mannitol · Drug: Bisacodyl
Drug page: Picosulfate sodium
Percentage of subjects classified as success (Aronchick scale)
Defined as excellent or good according to the Aronchick scale
Time frame: At visit 2 (day 1 of colonoscopy)
Percentage of subjects classified as success (Ottawa scale)
Defined as excellent, good or fair according to the Ottawa scale
Time frame: At visit 2 (day 1 of colonoscopy)
Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)
As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire
Time frame: At visit 2 (day 1 of colonoscopy)
Subject satisfaction (Likert scale)
As assessed by a subject survey using a 3 point Likert scale
Time frame: At visit 2 (day 1 of colonoscopy)
The record gives a start of Feb 2015, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Picosulfate sodium