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

Completed

• Conditions: Idiopathic Parkinson's Disease

• Registration Number: NCT01159691
• Lead Sponsor: UCB Pharma GmbH

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®.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-03-11
• Results First Submitted QC: 2013-03-11
• Results First Posted: 2013-04-23
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)	From Baseline to Visit 3 (approximately 6 weeks)	Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.
Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints	From Baseline to Visit 3 (approximately 6 weeks)	Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day).; For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12).; Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2	At Visit 2 (after approximately 2-4 weeks)	Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing; * Very satisfied; * Satisfied; * Moderately satisfied; * Not satisfied.
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3	At Visit 3 (after approximately 6 weeks)	Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing; * Very satisfied; * Satisfied; * Moderately satisfied; * Not satisfied.

Trial Locations

Locations (21)

28; 🇩🇪 Goettingen, Germany

02; 🇩🇪 Berlin, Germany

35; 🇩🇪 Nürnberg, Germany

24; 🇩🇪 Bochum, Germany

7; 🇩🇪 Köln, Germany

38; 🇩🇪 Buchholz, Germany

30; 🇩🇪 Erbach, Germany

22; 🇩🇪 Schriesheim, Germany

14; 🇩🇪 Gera, Germany

16; 🇩🇪 Karlstadt, Germany

31; 🇩🇪 Neuburg, Germany

34; 🇩🇪 Schwäbisch Gmünd, Germany

21; 🇩🇪 Stadtroda, Germany

1; 🇩🇪 Ulm, Germany

39; 🇩🇪 Lüneburg, Germany

40; 🇩🇪 Lauf an der Pegnitz, Germany

37; 🇩🇪 München, Germany

29; 🇩🇪 Wolfratshausen, Germany

36; 🇩🇪 Stuttgart, Germany

32; 🇩🇪 Ulm, Germany

12; 🇩🇪 Stuttgart, Germany