Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch

NCT ID: NCT01159691

Last Updated: 2013-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-03-31

Brief Summary

The study intends to collect data on gastrointestinal symptoms (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient satisfaction under everyday practice conditions after changing treatment to Neupro® transdermal patch in patients suffering from idiopathic Parkinson´s Disease with gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide any relief in gastrointestinal symptoms.

Detailed Description

Routine treatment as per approved label in Europe in accordance with the terms of the local marketing authorization for Neupro®.

Conditions

Idiopathic Parkinson's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neupro

Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• The decision to prescribe Neupro® must have been made by the physician before and independently of his/her decision to include the patient in the study
• The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro®
• The patient must have a diagnosis of Idiopathic Parkinson's disease
• The patient must have signed the Consent form regarding study information, data transfer and use
• Patient suffering from gastrointestinal symptoms while being treated with oral Parkinson's medication

Exclusion Criteria

Not applicable

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

02

Berlin, , Germany

24

Bochum, , Germany

38

Buchholz, , Germany

7

Cologne, , Germany

30

Erbach im Odenwald, , Germany

14

Gera, , Germany

28

Göttingen, , Germany

16

Karlstadt am Main, , Germany

40

Lauf an der Pegnitz, , Germany

39

Lüneburg, , Germany

37

München, , Germany

31

Neuburg am Inn, , Germany

35

Nuremberg, , Germany

22

Schriesheim, , Germany

34

Schwäbisch Gmünd, , Germany

21

Stadtroda, , Germany

12

Stuttgart, , Germany

36

Stuttgart, , Germany

1

Ulm, , Germany

32

Ulm, , Germany

29

Wolfratshausen, , Germany

Countries

Germany

References

Woitalla D, Kassubek J, Timmermann L, Lauterbach T, Berkels R, Grieger F, Muller T. Reduction of gastrointestinal symptoms in Parkinson's disease after a switch from oral therapy to rotigotine transdermal patch: a non-interventional prospective multicenter trial. Parkinsonism Relat Disord. 2015 Mar;21(3):199-204. doi: 10.1016/j.parkreldis.2014.11.024. Epub 2014 Dec 4.

Reference Type: DERIVED

PMID: 25595315 (View on PubMed)

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

SP0970

Identifier Type: -

Identifier Source: org_study_id