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

Fibromyalgia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00696787
• Other study ID #: 3151A4-2003
• Status: Terminated
• Phase: Phase 2
• First received: June 11, 2008
• Last updated: February 20, 2013
• Start date: June 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Desvenlafaxine Sustained Release (DVS SR)

• Lyrica® (Pregabalin)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline on the Numeric Rating Scale (NRS)	The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.	Baseline and 8 weeks	No
Secondary	Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients	The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.	Baseline and 8 weeks	No