Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

NCT ID: NCT01619566

Last Updated: 2019-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Control subjects undergo a skin biopsy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

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

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Cymbalta

Eligibility Criteria

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Inclusion Criteria

* Fibromyalgia Diagnosis
* Female
* Over the age of 18, under the age of 70
* Understands English
* Not Pregnant/planning to become pregnant


* 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


* No major psychiatric disorders
* No major unconrolled systemic diseases which may require hospitalization in the next 6 months
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Tobias Moeller-Bertram

Associate Clinical Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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tobias moeller-bertram, MD

Role: PRINCIPAL_INVESTIGATOR

employee

Locations

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University of California, San Diego Medical Centers

San Diego, California, United States

Site Status

Countries

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United States

Related Links

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http://www.cymbalta.com/Pages/index.aspx

Drug manufacturers website for study drug

http://health.ucsd.edu

Website for location of study

Other Identifiers

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111654

Identifier Type: -

Identifier Source: org_study_id

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