Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch (NON-GI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01159691
First received: July 8, 2010
Last updated: May 13, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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
Study Population

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).

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159691

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
Sponsors and Collaborators
UCB Pharma GmbH
Investigators
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 July 22, 2014