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

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.

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Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

02, Berlin, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

UCB Pharma GmbH

Industry

Registry information

Official study title

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

Acronym: NON-GI

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jul 9, 2010
Registry last updated: May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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