A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Col… (NCT02386449) | Clinical Trial Compass
CompletedPhase 4
A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy
Brazil184 participantsStarted 2015-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women aged 18 to 60 years
* Subjects scheduled for an elective colonoscopy
* Women of child-bearing potential using at least one highly effective contraceptive method
* Subjects able to understand all instructions
* Informed consent signed
Exclusion Criteria:
* Hypersensitivity to active ingredients
* Female participants pregnant or with a positive blood pregnancy test
* Acute surgical abdomen
* Previous colorectal surgery
* Gastrointestinal (GI) surgery
* GI diseases, active inflammatory bowel disease, colon disease
* Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease
* Use of laxatives or antidiarrheal agents 72 hours prior to screening
* Significant alterations in laboratory values or other diseases that could interfere with the results
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects classified as success (Aronchick scale)