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Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome

NCT00445705 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2015-09-07

Study results available
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Summary

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Conditions

  • Fibromyalgia

Interventions

DRUG

placebo

Part A: Placebo every 12 hours for 4 weeks

DRUG

AGN 203818

Part A: AGN 203818 3 mg every 12 hours for 4 weeks

DRUG

AGN 203818

Part A: AGN 203818 20 mg every 12 hours for 4 weeks

DRUG

AGN 203818

Part A: AGN 203818 60 mg every 12 hours for 4 weeks

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • Switzerland
  • United Kingdom

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 NCT00445705 on ClinicalTrials.gov