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NCT00375973 · ClinicalTrials.gov registry record · Phase 2

Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

A Phase 2 study, sponsored by University of Cincinnati.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT00375973: Completed Phase 2 study, sponsored by University of Cincinnati.

NCT00375973 is a Phase 2 study that has completed, run by University of Cincinnati. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00375973, a Phase 2 study, has completed, sponsored by University of Cincinnati.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).

Primary Outcome

The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement. The general fatigue subscale (primary measure) includes general statemen

Interventions

  • DRUG Placebo
  • DRUG Duloxetine

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2006-09
Est. Completion 2014-03
Phase Phase 2
University of Cincinnati

245 total trials

What the finished NCT00375973 record still lists

NCT00375973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00375973 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00375973 about?

NCT00375973 is a clinical study titled "Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome". The purpose of this study is to determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).

What is the current status of trial NCT00375973?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2006-09. Estimated completion is 2014-03.

What interventions are being tested in trial NCT00375973?

The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG).

Who is sponsoring clinical trial NCT00375973?

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

How this trial's enrollment target compares

Where NCT00375973's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00375973, the US trial registry maintained by the National Library of Medicine. NCT00375973 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.