Study Condition(s): Fibromyalgia

A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Study Alias: HMGW

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT01237587 {{ currentLocaleObject.registryAnchorText }}

Recruiting Recruiting

Study Purpose

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.

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

13 years
17 years

Time Commitment

Your participation could last up to 39 weeks and include 15 visits to the study center
  • 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

Where to Participate

32 locations are currently available of 40 planned
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