N/A
N=76
Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch
Idiopathic Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01159691 ↗Enrolled (actual)
76
Serious AEs
5.3%
Results posted
Apr 2013
Primary outcome: 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) — -26.8 millimeter (mm)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- UCB Pharma GmbH
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
-26.8 | — |
| PRIMARY Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints |
-8.4 | — |
| PRIMARY Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 |
1; 25; 26; 8; 5 | — |
| PRIMARY Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 |
7; 28; 22; 6; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01159691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.