Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482170
Status:
COMPLETED
Last Update Posted:
2012-03-30
First Post:
2007-06-01
Brief Title:
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A 3 Month Randomised Open Label Parallel Group Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept Etanercept Auto-injector and the Etanercept Prefilled Syringe in Patients With Psoriasis
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective of this study is to compare patient satisfaction with the prefilled syringe PFS and the auto-injector AI two different delivery devices for etanercept after 12 weeks of use using a 10 point scale form totally dissatisfied to totally satisfiedSecondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction
Detailed Description:
For the measures of patients satisfaction with and perceptions of their device standard Likert scales are used This allows the magnitude of individuals perceptions and satisfaction to be measured on a multipoint scale anchored at each end In addition the study will describe patient perceptions related to device attributes which are of importance in describing overall patient perception A range of potential device benefits eg ease of use convenience injection site pain injection anxiety injection confidence will be captured using a questionnaire The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another Patient attributes are composed of patient characteristics eg age sex demographics social and educational status psychological status willingness to self-manage injection experience and Psoriasis characteristics eg disease severity disease duration co morbidities prior treatment quality of life The study will also take the opportunity to measure health outcome measures as there may be important differences in cost of training and patient support between the two devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None