CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 530 enrolled
Drug / intervention
duloxetine hydrochloride +1 moredrug
Likely dose
duloxetine hydrochloride 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00673452
NCT00673452Phase 4Completed
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Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia

Eli Lilly and Company·interventional·Posted May 7, 2008·Updated Jun 24, 2010

In Brief

A Phase 4 clinical trial evaluating duloxetine hydrochloride and placebo for Fibromyalgia. Completed, enrolled 530 participants across 46 sites in 2 countries.

Detailed Summary

The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesPuerto Rico, United States
CollaboratorsBoehringer Ingelheim

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.2 years ago

Interventions

duloxetine hydrochloridedrug

60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).

placebodrug

oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)