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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This study has been withdrawn prior to enrollment.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
  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:
  • Pain Reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2012
Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

Locations
United States, California
University of California, San Diego Medical Centers
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: tobias moeller-bertram, MD employee
  More Information

Additional Information:
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: October 24, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents

ClinicalTrials.gov processed this record on December 07, 2016