Study Condition(s): Fibromyalgia
A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Study Alias: HMGW
The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS). This trial consists of two distinct study periods; a blinded treatment period of 13 weeks and an open label extension period of 26 weeks.
The results of this study are not yet available.
Here you can find out a bit more about the requirements for volunteers who took part in this study
Female participant must have a negative serum pregnancy test during screening
Participant and participant's parent/legal representative must agree to keep all appointments for clinical tests and procedures
Participant must be capable of swallowing study drug (pill) whole
Participant must allow blood samples to be collected and be compliant with blood draws
Participant must not have been treated with duloxetine within the last 6 months
Participant must not have a current diagnosis of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or an autoimmune disease (for example, systemic lupus erythematosus)
Participant must not have positive urine drug screen for any substances of abuse
Participant must not have taken fluoxetine within 30 days prior to screening
Participant must not have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C)
Female participant must not be pregnant, nursing or have recently given birth