Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-28 @ 9:17 AM
Study NCT ID:
NCT01619566
Status:
WITHDRAWN
Last Update Posted:
2019-08-09
First Post:
2012-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Duloxetine (Cymbalta): for Fibromyalgia: An Open Label Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therpeutic Responsiveness to Duloxetine.
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor related
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.
Detailed Description:
Subjects will have skin biopsies taken and evaluated for specific pathologies. All subjects will undergo a treatment period with Duloxetine. The analysis will correlate treatment effectiveness with pathological skin biopsy findings to predict future treatment success.
Study Oversight
Has Oversight DMC:
True
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?: