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OpenTrials
Completed

NCT Number: NCT00125892

A Study of Duloxetine in the Treatment of Fibromyalgia

This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome patients.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet criteria for primary fibromyalgia syndrome as defined by the American College of Rheumatologists

Exclusion criteria

  • Treatment with a monoamine oxidase inhibitor within 14 days prior to Visit 2 or the potential need to take within 5 days after discontinuation from the study.
  • Any patients judged by their physicians to be at serious suicidal risk.
  • Have uncontrolled narrow-angle glaucoma

Treatment and study plan

Duloxetine

Drug

Primary outcomes

  1. Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome

Secondary outcomes

  1. Evaluate persistence of efficacy

  2. Evaluate long-term differences in efficacy in different doses

  3. Evaluate gains in efficacy in non-responders

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

A 1-Year Safety Study of Duloxetine in Patients With Fibromyalgia Syndrome

Important dates

Study start
2005
Study completion
2007
First posted
Aug 2, 2005
Registry last updated
May 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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