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

Allergan

Status and phase: Terminated; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: AGN 203818; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445705

203818-503

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of fibromyalgia syndrome
• Moderate or severe pain associated with fibromyalgia

Exclusion criteria

• Any other uncontrolled disease
• Pregnant or nursing females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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211 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Part A: Placebo every 12 hours for 4 weeks

Treatment:

Drug: placebo

AGN 203818 3 mg

Experimental group

Description:

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

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818

AGN 203818 20 mg

Experimental group

Description:

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

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818

AGN 203818 60 mg

Experimental group

Description:

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

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818