Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

Phase 4

Withdrawn

• Conditions: Fibromyalgia
• Interventions: Drug: Duloxetine

• Registration Number: NCT01619566
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain Reduction	12 weeks	Changes in Pain measured by Numeric Pain Rating Scale over time. The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer.

Trial Locations

Locations (1)

University of California, San Diego Medical Centers; 🇺🇸 San Diego, California, United States