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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00696787
First received: June 11, 2008
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Desvenlafaxine Sustained Release (DVS SR)
Drug: Lyrica® (Pregabalin)
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Change From Baseline on the Numeric Rating Scale (NRS) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 125
Study Start Date: June 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
Drug: Placebo
Experimental: DVS SR
In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
Drug: Desvenlafaxine Sustained Release (DVS SR)
Active Comparator: Pregabalin
In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Drug: Lyrica® (Pregabalin)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696787

  Show 27 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00696787     History of Changes
Other Study ID Numbers: 3151A4-2003
Study First Received: June 11, 2008
Results First Received: January 29, 2010
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
O-desmethylvenlafaxine
Pregabalin
Analgesics
Anticonvulsants
Antidepressive Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014