A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

Wyeth

Status and phase: Terminated; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: Lyrica® (Pregabalin); Drug: Placebo; Drug: Desvenlafaxine Sustained Release (DVS SR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696787

3151A4-2003

Details and patient eligibility

About

The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.

Enrollment: 125 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

Exclusion criteria

• Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
• Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
• Treatment with other drugs for fibromyalgia with 14 days of study start or during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.

Treatment:

Drug: Placebo

DVS SR

Experimental group

Description:

In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.

Treatment:

Drug: Desvenlafaxine Sustained Release (DVS SR)

Pregabalin

Active Comparator group

Description:

In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.

Treatment:

Drug: Lyrica® (Pregabalin)