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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: February 6, 2017
Last verified: February 2017
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      6 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.3  (1.25) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6 100.0% 
Male      0   0.0% 
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
  Show All Outcome Measures

1.  Primary:   Average Pain Severity Score   [ Time Frame: Daily on average in the past week. ]

2.  Secondary:   The Clinical Global Impression of Severity   [ Time Frame: at the time of the assessment ]

3.  Secondary:   The Patient Global Impression of Improvement   [ Time Frame: since baseline, at the time of the assessment ]

4.  Secondary:   The Functional Disability Inventory-child Version   [ Time Frame: Over the "last few days." ]

5.  Secondary:   The Functional Disability Inventory-parent Version   [ Time Frame: Over the "last few days." ]

6.  Secondary:   Children's Depression Inventory   [ Time Frame: Over the past 2 weeks. ]

7.  Secondary:   Multidimensional Anxiety Scale for Children   [ Time Frame: Over the past week. ]

8.  Secondary:   Fibromyalgia Impact Questionnaire Modified for Children   [ Time Frame: Over the past week. ]


  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



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: February 6, 2017