Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

University of California San Diego

Status and phase: Withdrawn; Phase 4

Conditions: Fibromyalgia

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT01619566

111654

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control

No Intervention group

Description:

Control subjects undergo a skin biopsy.

Treatment

Experimental group

Description:

Subjects in the treatment arm also undergo a skin biopsy, followed by 8 week treatment with Duloxetine.

Treatment:

Drug: Duloxetine