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

Idiopathic Parkinson's Disease Clinical Trial

— NON-GI  

Official title:

A Multicentric, Non-interventional Study on Switching From Oral Parkinson Therapy to Neupro® in Patients With Idiopathic Parkinson's Disease With Gastrointestinal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159691
• Other study ID #: SP0970
• Status: Completed
• Phase: N/A
• First received: July 8, 2010
• Last updated: May 13, 2013
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Locations

Country	Name	City	State
Germany	02	Berlin
Germany	24	Bochum
Germany	38	Buchholz
Germany	30	Erbach
Germany	14	Gera
Germany	28	Goettingen
Germany	16	Karlstadt
Germany	7	Köln
Germany	40	Lauf an der Pegnitz
Germany	39	Lüneburg
Germany	37	München
Germany	31	Neuburg
Germany	35	Nürnberg
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

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)	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.	From Baseline to Visit 3 (approximately 6 weeks)	No
Primary	Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints	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.	From Baseline to Visit 3 (approximately 6 weeks)	No
Primary	Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2	Patient satisfaction referring to GI complaints is classified into 5 categories: Missing; Very satisfied; Satisfied; Moderately satisfied; Not satisfied.	At Visit 2 (after approximately 2-4 weeks)	No
Primary	Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3	Patient satisfaction referring to GI complaints is classified into 5 categories: Missing; Very satisfied; Satisfied; Moderately satisfied; Not satisfied.	At Visit 3 (after approximately 6 weeks)	No

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