Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lesley M. Arnold, M.D., University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00115804
First received: June 26, 2005
Last updated: January 15, 2013
Last verified: January 2013
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Juvenile Primary Fibromyalgia Syndrome (JPFS)
Fibromyalgia
Intervention: Drug: Fluoxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Female or male patients from Children's Hospital pediatric outpatient rheumatology clinic were eligible for the trial if they were 13 to 17 years and met study criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who met entry criteria for juvenile fibromyalgia but did not meet any exclusion criteria.

Reporting Groups
  Description
Fluoxetine All patients receiving Fluoxetine starting at 10 mg/day

Participant Flow:   Overall Study
    Fluoxetine  
STARTED     6  
COMPLETED     4  
NOT COMPLETED     2  
Adverse Event                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fluoxetine All eligible patients were given fluoxetine

Baseline Measures
    Fluoxetine  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     6  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  15.3  ± 1.25  
Gender  
[units: participants]
 
Female     6  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     6  
Average Pain Severity [1]
[units: mm]
Mean ( Full Range )
  62  
  ( 47 to 76 )  
[1] The average pain severity on the Pediatric Pain Questionnaire’s 100-mm visual analog scale. This is a 100-mm horizontal line on which the patient’s pain intensity is represented by a point between the extremes of zero “no pain at all” and 100 “worst pain imaginable.”



  Outcome Measures

1.  Primary:   Average Pain Severity Score   [ Time Frame: 12 weeks ]

2.  Secondary:   The Clinical Global Impression of Severity Scale Evaluates the Severity of Illness at the Time of Assessment.   [ Time Frame: at the time of the assessment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   The Patient Global Impression of Improvement Measures the Degree of Improvement Since Randomization at the Time of the Assessment.   [ Time Frame: since randomization at the time of the assessment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   The Functional Disability Inventory-child Version Assesses Perceived Difficulty in Performing Activities in the Domains of School, Home, Recreation, and Social Interactions.   [ Time Frame: at the time of the assessment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   The Functional Disability Inventory-parent Version Consists of the Same 15 Items as the Child Version But Allows the Parent to Provide Their Perception of the Child's Difficulty in Performing Activities in Physical and Psychosocial Domains.   [ Time Frame: at the time of the assessment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Children's Depression Inventory is a Self-reported Scale That is Widely Used in Studies of Children With Fibromyalgia.   [ Time Frame: at the time of the assessment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Multidimensional Anxiety Scale for Children is a Self-report Inventory That Assesses Four Areas of Anxiety Symptoms.   [ Time Frame: at the time of the assessment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Fibromyalgia Impact Questionnaire Modified for Children is a Self-report Instrument That Measures Function, Pain, Fatigue, Sleep Quality, Stiffness, Anxiety and Depression.   [ Time Frame: at the time of the assessment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Lesley Arnold
Organization: University of Cincinnati
phone: 513-475-8110
e-mail: lesley.arnold@uc.edu


No publications provided


Responsible Party: Lesley M. Arnold, M.D., University of Cincinnati
ClinicalTrials.gov Identifier: NCT00115804     History of Changes
Other Study ID Numbers: 05-3-22-1
Study First Received: June 26, 2005
Results First Received: November 7, 2012
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board