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Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

Primary Purpose

Fibromyalgia

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Duloxetine

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Duloxetine, Cymbalta, Pain, Peripheral Nerve, Biopsy, Predictive

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of California, San Diego Medical Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

Control subjects undergo a skin biopsy.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01619566

First Posted

June 12, 2012

Last Updated

August 7, 2019

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT01619566

Brief Title

Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor related

Study Start Date

June 2012 (undefined)

Primary Completion Date

January 2015 (Anticipated)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Duloxetine, Cymbalta, Pain, Peripheral Nerve, Biopsy, Predictive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control subjects undergo a skin biopsy.

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

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)

Primary Outcome Measure Information:

Title

Pain Reduction

Description

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

tobias moeller-bertram, MD

Organizational Affiliation

employee

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Diego Medical Centers

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

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

Description

Drug manufacturers website for study drug

URL

http://health.ucsd.edu

Description

Website for location of study

Learn more about this trial

Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

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