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NCT01619566 Clinical Trial

Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

Fibromyalgia Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01619566
Other study ID # 111654
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date June 2012
Est. completion date January 2015

Study information
Verified date August 2019
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
United States University of California, San Diego Medical Centers San Diego California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Reduction 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. 12 weeks
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