Cymbalta for Fibromyalgia Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Tobias Moeller-Bertram, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01619566
First received: June 12, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 12, 2012
June 12, 2012
June 2012
Not Provided
Nerve Histology [ Designated as safety issue: No ]
To determine if biopsied skin sample nerve ending morphology will be predictive of Duloxetine efficacy.
Same as current
No Changes Posted
Improved Pain Ratings [ Designated as safety issue: No ]
Decrease pain ratings after 8 week treatment.
Same as current
Not Provided
Not Provided
 
Cymbalta for Fibromyalgia Pain
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
Drug: 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
  • No Intervention: Control
    Control subjects undergo a skin biopsy.
  • Experimental: Treatment
    Subjects in the treatment arm also undergo a skin biopsy, followed by 8 week treatment with Duloxetine.
    Intervention: Drug: Duloxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
Not Provided

Inclusion Criteria: Treatment Arm

  • Fibromyalgia Diagnosis
  • Female
  • Over the age of 18, under the age of 70
  • Understands English
  • Not Pregnant/planning to become pregnant

Exclusion Criteria:

  • No major psychiatric disorders
  • No major unconrolled systemic diseases which may require hospitalization in the next 6 months
  • Pregnant

Inclusion Criteria: Control Arm

  • Female
  • Over the age of 18, under the age of 70
  • Understands English
  • Not Pregnant/planning to become pregnant

Exclusion Criteria: Control Arm

  • No major psychiatric disorders
  • No major unconrolled systemic diseases which may require hospitalization in the next 6 months
  • Pregnant
Female
18 Years to 70 Years
Yes
Contact: Meegin Kincaid, B.S. 858-552-8585 ext 2386 mjkinciad@ucsd.edu
United States
 
NCT01619566
111654
Yes
Tobias Moeller-Bertram, University of California, San Diego
University of California, San Diego
Not Provided
Not Provided
University of California, San Diego
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP