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
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Nerve Histology [ Designated as safety issue: No ]
    To determine if biopsied skin sample nerve ending morphology will be predictive of Duloxetine efficacy.


Secondary Outcome Measures:
  • Improved Pain Ratings [ Designated as safety issue: No ]
    Decrease pain ratings after 8 week treatment.


Estimated Enrollment: 30
Study Start Date: June 2012
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619566

Contacts
Contact: Meegin Kincaid, B.S. 858-552-8585 ext 2386 mjkinciad@ucsd.edu

Locations
United States, California
University of California, San Diego Medical Centers Recruiting
San Diego, California, United States, 92103
Contact: Meegin Kincaid, B.S.    858-552-8585    mjkincaid@ucsd.edu   
Principal Investigator: Tobias Moeller-Bertram, M.D., MAS         
Sponsors and Collaborators
University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Tobias Moeller-Bertram, Associate Clinical Professor of Anesthesia, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01619566     History of Changes
Other Study ID Numbers: 111654
Study First Received: June 12, 2012
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
Fibromyalgia
Duloxetine
Cymbalta
Pain
Peripheral Nerve
Biopsy
Predictive

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014