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Study of Milnacipran for the Treatment of Fibromyalgia

NCT00314249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1025

Last updated 2010-01-20

Study results available
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Summary

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Conditions

  • Fibromyalgia

Interventions

DRUG

Placebo

Placebo, oral administration, twice daily for 12 weeks

DRUG

Milnacipran 100mg

Milnacipran 100mg per day (50mg BID \[twice a day\])

Sponsors & Collaborators

  • Cypress Bioscience, Inc.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00314249 on ClinicalTrials.gov