Compliance and Efficacy in the Use of PICOPREP®

Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01220453

Acronym

CLEAR

Enrollment

2165

Registered

2010-10-14

Start date

2010-10-31

Completion date

2011-07-31

Last updated

2012-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Cleanliness

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Patients in which prescription of PICOPREP® is contraindicated

Design outcomes

Primary

Measure	Time frame	Description
Documentation of the use of PICOPREP® in every day practice	2 days	Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results