Compliance and Efficacy in the Use of PICOPREP®
- Conditions
- Bowel Cleanliness
- Registration Number
- NCT01220453
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
The present trial is aimed to document efficacy (bowel cleanliness), acceptance and tolerability as well as patient comfort in the use of the new bowel cleansing product PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2165
- Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery
- Patients who have been informed about the NIS and have given their written consent for participation
- Patients in which prescription of PICOPREP® is contraindicated
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Documentation of the use of PICOPREP® in every day practice 2 days Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort
- Secondary Outcome Measures
Name Time Method Documentation of patient satisfaction after bowel cleansing 2 days Documentation of examiner satisfaction after colonoscopy 2 days Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups) 2 days Tolerability: frequency and severity of adverse events 2 days
Trial Locations
- Locations (3)
Investigational site
🇩🇪Singen, Germany
Investigational Site
🇩🇪Wriezen, Germany
Private Practice
🇩🇪Bietigheim-Bissingen, Germany