Study Stopped
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Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed
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.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedAugust 9, 2019
August 1, 2019
2.6 years
June 12, 2012
August 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Reduction
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.
12 weeks
Study Arms (2)
Control
NO INTERVENTIONControl subjects undergo a skin biopsy.
Treatment
EXPERIMENTALSubjects in the treatment arm also undergo a skin biopsy, followed by 8 week treatment with Duloxetine.
Interventions
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)
Eligibility Criteria
You may qualify if:
- Fibromyalgia Diagnosis
- Female
- Over the age of 18, under the age of 70
- Understands English
- Not Pregnant/planning to become pregnant
You may not qualify if:
- No major psychiatric disorders
- No major unconrolled systemic diseases which may require hospitalization in the next 6 months
- Pregnant
- Female
- Over the age of 18, under the age of 70
- Understands English
- Not Pregnant/planning to become pregnant
- No major psychiatric disorders
- No major unconrolled systemic diseases which may require hospitalization in the next 6 months
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Diego Medical Centers
San Diego, California, 92103, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
tobias moeller-bertram, MD
employee
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Clinical Professor of Anesthesia
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 14, 2012
Study Start
June 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
August 9, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share