Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch (NON-GI)
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Idiopathic Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- 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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Patient satisfaction referring to GI complaints is classified into 5 categories:
- Missing
- Very satisfied
- Satisfied
- Moderately satisfied
- Not satisfied.
| Enrollment: | 76 |
| Study Start Date: | June 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Neupro
Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
|
Detailed Description:
Routine treatment as per approved label in Europe in accordance with the terms of the local marketing authorization for Neupro®.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Parkinson's Disease (PD) suffering from gastrointestinal complaints under oral anti-parkinson treatment; treated in Germany by neurological outpatient centers (clinic/ practice of neurologist).
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
Contacts and Locations| 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, Germany | |
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. ( UCB Pharma GmbH ) |
| ClinicalTrials.gov Identifier: | NCT01159691 History of Changes |
| Other Study ID Numbers: | SP0970 |
| Study First Received: | July 8, 2010 |
| Results First Received: | March 11, 2013 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by UCB, Inc.:
|
Rotigotine Neupro® Parkinson's disease Gastrointestinal Switch from oral therapy to patch |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
N 0437 Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013