Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01619566|
Recruitment Status : Withdrawn (Sponsor related)
First Posted : June 14, 2012
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Duloxetine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
No Intervention: Control
Control subjects undergo a skin biopsy.
Subjects in the treatment arm also undergo a skin biopsy, followed by 8 week treatment with Duloxetine.
oral tablet, 30mg daily for 1 week (titration up) oral tablet, 60mg daily for 8 weeks (treatment) oral tablet, 30mg daily for 1 week (titration down, if needed)
Other Name: Cymbalta
- Pain Reduction [ Time Frame: 12 weeks ]Changes in Pain measured by Numeric Pain Rating Scale over time. The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619566
|United States, California|
|University of California, San Diego Medical Centers|
|San Diego, California, United States, 92103|
|Principal Investigator:||tobias moeller-bertram, MD||employee|