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Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

This study has been withdrawn prior to enrollment.
(Sponsor related)
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: October 24, 2016
Last verified: October 2016

June 12, 2012
October 24, 2016
June 2012
January 2015   (final data collection date for primary outcome measure)
Pain Reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Nerve Histology [ Designated as safety issue: No ]
To determine if biopsied skin sample nerve ending morphology will be predictive of Duloxetine efficacy.
Complete list of historical versions of study NCT01619566 on ClinicalTrials.gov Archive Site
Not Provided
Improved Pain Ratings [ Designated as safety issue: No ]
Decrease pain ratings after 8 week treatment.
Not Provided
Not Provided
 
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.
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.
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.
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.
 
Withdrawn
0
January 2015
January 2015   (final data collection date for primary outcome measure)

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   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01619566
111654
Yes
No
Not Provided
Tobias Moeller-Bertram, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: tobias moeller-bertram, MD employee
University of California, San Diego
October 2016

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