NCT01292109

Brief Summary

The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

9 months

First QC Date

February 8, 2011

Last Update Submit

February 8, 2012

Conditions

Bowel Cleanliness

Keywords

endoscopycolonoscopypreparation for surgery

Outcome Measures

Primary Outcomes (1)

  • Documentation of use PICOPREP in everyday practice

    Day 0 - 2

Secondary Outcomes (2)

  • Participant satisfaction and compliance after bowel cleansing

    Days 0-2

  • Participants with adverse events reported by frequency and severity

    Days 1-2

Study Arms (1)

PICOPREP®

Drug: sodium picosulphate

Interventions

sodium picosulphateDRUG

Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.

Also known as: PICOPREP®
PICOPREP®

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients about to undergo X-ray examination, endoscopy or surgery.

You may qualify if:

  • Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery

You may not qualify if:

  • Patients in which prescription of PICOPREP® is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital

Ostrava - Poruba, Czechia

Location

University Hospital

Pilsen, Czechia

Location

Iscare - Prague 7

Prague, Czechia

Location

MeSH Terms

Interventions

picosulfate sodium

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 9, 2011

Study Start

December 1, 2010

Primary Completion

September 1, 2011

Study Completion

February 1, 2012

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

CZ(3)