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NCT00115804 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

A Phase 3 study of Fibromyalgia and Juvenile Primary Fibromyalgia Syndrome (JPFS), sponsored by University of Cincinnati.

Completed
Registry status
Phase 3
Development phase
6
Enrollment target
1
Study location

NCT00115804: Completed Phase 3 study of Fibromyalgia and Juvenile Primary Fibromyalgia Syndrome (JPFS), sponsored by University of Cincinnati.

NCT00115804 is a Phase 3 study of Fibromyalgia and Juvenile Primary Fibromyalgia Syndrome (JPFS) that has completed, run by University of Cincinnati. The registered enrollment target is 6 participants, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00115804, a Phase 3 study of Fibromyalgia and Juvenile Primary Fibromyalgia Syndrome (JPFS), has completed, sponsored by University of Cincinnati.

COMPLETED
Registry status
Phase 3
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

The purpose of this research is to conduct an open, pilot trial to assess the efficacy and safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).

Primary Outcome

The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale. (0=no pain and 100 = severe pain )

Interventions

  • DRUG Fluoxetine

Study Locations (1)

Ohio

  • Women's Health Research Program - Cincinnati

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2005-06
Est. Completion 2011-02
Phase Phase 3
University of Cincinnati

245 total trials

What the finished NCT00115804 record still lists

NCT00115804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Fibromyalgia appearing as the primary indexed condition, and to 1 intervention - of which Fluoxetine is the first listed.

NCT00115804 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT00115804 about?

NCT00115804 is a clinical study titled "Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia". The purpose of this research is to conduct an open, pilot trial to assess the efficacy and safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).

What is the current status of trial NCT00115804?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2005-06. Estimated completion is 2011-02.

What conditions does trial NCT00115804 study?

This clinical trial studies the following conditions: Fibromyalgia, Juvenile Primary Fibromyalgia Syndrome (JPFS).

What interventions are being tested in trial NCT00115804?

The interventions under investigation include: Fluoxetine (DRUG).

Who is sponsoring clinical trial NCT00115804?

This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00115804 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Fibromyalgia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00115804's enrollment target sits among peer trials

6 76th of 76 the lowest of 76 other Fibromyalgia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Fibromyalgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00115804, the US trial registry maintained by the National Library of Medicine. NCT00115804 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.