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
Results First Received: March 11, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Idiopathic Parkinson's Disease

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study started to enroll subjects in June 2010 in order to end up with 21 centers in Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
76 patients were included in the Enrolled Set (ES), 75 of whom were treated with Neupro® at least once during the Observational Period and, thus, constituted the Safety Set (SS). The Full Analysis Set (FAS) encompassed all 65 patients who had been treated with Neupro® at least once and who had valid Baseline and Follow-up Visit values.

Reporting Groups
  Description
Neupro Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.

Participant Flow:   Overall Study
    Neupro  
STARTED     76  
COMPLETED     54 [1]
NOT COMPLETED     22  
Lost to Follow-up                 2  
Unknown reasons                 1  
Discontinued Neupro due to Adverse Event                 6  
Discontinued Neupro due to other reasons                 1  
Disc. Neupro other & lost to follow-up                 2  
Disc. Neupro other & unknown reasons                 7  
Disc. Neupro due to AE & unknown reasons                 2  
Disc. Neupro lack of efficacy & unknown                 1  
[1] Multiple discontinuation reasons were possible.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Characteristics show the Enrolled Set (ES). ES encompasses those patients who have been included in this study and for whom data are available on the first Visit (initial examination).

Reporting Groups
  Description
Neupro Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.

Baseline Measures
    Neupro  
Number of Participants  
[units: participants]
  76  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     62  
Age  
[units: years]
Mean ± Standard Deviation
  70.3  ± 9.8  
Gender  
[units: participants]
 
Female     31  
Male     45  
Region of Enrollment  
[units: participants]
 
Germany     76  
Weight  
[units: kilogram¬†(kg)]
Mean ± Standard Deviation
  78.1  ± 12.9  
Height  
[units: centimeter¬†(cm)]
Mean ± Standard Deviation
  171.1  ± 9.6  



  Outcome Measures
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1.  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)   [ Time Frame: From Baseline to Visit 3 (approximately 6 weeks) ]

2.  Primary:   Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints   [ Time Frame: From Baseline to Visit 3 (approximately 6 weeks) ]

3.  Primary:   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) ]

4.  Primary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


No publications provided


Responsible Party: UCB Pharma ( 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