Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01280747
Status:
TERMINATED
Last Update Posted:
2021-01-26
First Post:
2011-01-19
Brief Title:
Examination of Pregabalin Access for Treatment of Indicated Pain Disorders the ExPAND Study
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
Examination of Pregabalin Access for Treatment of Indicated Pain Disorders the ExPAND Study
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators hypothesize that fibromyalgia FM and painful diabetic peripheral neuropathy pDPN patients with access restrictions on pregabalin will lead to higher healthcare resource use and cost compared to patients without such restrictions on pregabalin in a naturalistic setting The randomization will occur at the physician level and not the patient level
Detailed Description:
This trial was terminated prematurely on April 2 2012 due to the inability to recruit the planned number of subjects The decision to terminate the trial was not based on any safety or efficacy concerns
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