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 Pharma ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01159691
First received: July 8, 2010
Last updated: May 13, 2013
Last verified: May 2013

July 8, 2010
May 13, 2013
June 2010
March 2012   (final data collection date for primary outcome measure)
  • 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.
  • Severity of Gastrointestinal Complaints [ Time Frame: From Baseline to approximately 6 weeks ] [ Designated as safety issue: No ]
    Change from Baseline to approximately 6 weeks in the assessment of severity of gastrointestinal complaints for any reason as per visual analogue scale (VAS)
  • Sum Score of Gastrointestinal Complaints [ Time Frame: From Baseline to approximately 6 weeks ] [ Designated as safety issue: No ]
    Change from Baseline to approximately 6 weeks in the sum score of gastrointestinal complaints calculated from frequency and intensity of the symptoms
  • Patient Satisfaction [ Time Frame: After 2 weeks and after approximately 6 weeks ] [ Designated as safety issue: No ]
    Assessment of patient satisfaction referring to gastrointestinal complaints following treatment switch to Neupro
Complete list of historical versions of study NCT01159691 on ClinicalTrials.gov Archive Site
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Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch
A Multicentric, Non-interventional Study on Switching From Oral Parkinson Therapy to Neupro® in Patients With Idiopathic Parkinson's Disease With Gastrointestinal Symptoms

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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).

Idiopathic Parkinson's Disease
Not Provided
Neupro
Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
March 2012
March 2012   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01159691
SP0970
No
UCB Pharma ( UCB Pharma GmbH )
UCB Pharma GmbH
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP